Trial Outcomes & Findings for A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer (NCT NCT00148122)

Last Updated: 2014-04-17

Results Overview

Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

4 months

Results posted on

2014-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel and Capecitabine Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel and Capecitabine Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=38 Participants Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Age, Continuous	59.46 years n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	32 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	36 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	38 participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Asymptomatic)	27 participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Symptomatic but Completely Ambulatory)	9 participants n=99 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 (Symtomatic; <50% in Bed During the Day)	2 participants n=99 Participants
Histology Squamous Cell Cancer	36 participants n=99 Participants
Histology Adenocarcinoma	1 participants n=99 Participants
Histology Others	1 participants n=99 Participants
Disease Extent Local Regional	13 participants n=99 Participants
Disease Extent Distant	17 participants n=99 Participants
Disease Extent Local Regional Distant	7 participants n=99 Participants
Disease Extent Missing	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 4 months

Population: 40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.

Outcome measures

Outcome measures
Measure	Arm 1 n=36 Participants Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Overall Response Rate at 4 Months	16 percentage of participants

SECONDARY outcome

Timeframe: 30 days post treatment

Population: 40 patients were enrolled. 2 patients withdrew consent, therefore only 38 were included in the toxicity analysis.

The frequency of grade 3 and grade 4 adverse events experienced by all treated participants.

Outcome measures

Outcome measures
Measure	Arm 1 n=38 Participants Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Febrile Neutropenia	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Lymphopenia	8 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Infection w/o Neutropenia	5 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Fatigue	4 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Leukocytes	4 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Stomatitis	4 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Neutrophils	3 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Diarrhea	2 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Hand-Foot Skin Reaction	2 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Hemoglobin	2 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Platelets	2 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Allergic Reaction	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Anorexia	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Cardiac-Ischemia	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Dysphagia	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Dyspnea	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Abnormal ENT Examination	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Edema Limbs	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Hand-Foot Syndrome	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Hyperglycemia	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Hyponatremia	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Infection with Unknown ANC	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Infection, Lung	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Melena	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Mental Status Changes	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Mucositis	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Nausea	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Oral Pain	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Pain, Extremity	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Pharyngolaryngeal Pain	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 AST Elevation	1 participants
Frequency of Grade III/IV Toxicities Experienced by Participants Grade 3 and 4 Vomiting	1 participants

SECONDARY outcome

Timeframe: 1 year post treatment

The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval).

Outcome measures

Outcome measures
Measure	Arm 1 n=36 Participants Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Probability of Progression Free Survival	25 percentage of patients Interval 12.4 to 39.8

Adverse Events

Arm 1

Serious events: 25 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=38 participants at risk Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Investigations Alanine aminotransferase increased	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Aspartate aminotransferase increased	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders CNS hemorrhage/bleeding	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Cardiac disorders Cardiac-ischemia/infarction	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Cardiac disorders Chest pain	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Constipation	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Constitutional Symptoms-Other	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Diarrhea (no colostomy)	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Blood and lymphatic system disorders Febrile neutropenia	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Hemoptysis	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Injury, poisoning and procedural complications Hemorrhage-Other	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hypercalcemia	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Infections and infestations Infection with unknown ANC	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Infections and infestations Infection, Lung (pneumonia)	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Melena/GI bleeding	2.6% 1/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Psychiatric disorders Mental status changes	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Nausea	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Neck pain	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders Neuropathy - motor	2.6% 1/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Pain-Other	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Cardiac disorders Pericardial effusion/pericarditis	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Infections and infestations Skin infection	2.6% 1/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Stomatitis/pharyngitis	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Syndromes-Other	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Vascular disorders Thrombosis	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Eye disorders Vision-double vision (diplopia)	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Vital capacity decreased	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Vomiting	2.6% 1/38 • Number of events 1 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.

Other adverse events

Other adverse events
Measure	Arm 1 n=38 participants at risk Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, \&15) Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule. Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.
Gastrointestinal disorders Abdominal pain or cramping	10.5% 4/38 • Number of events 6 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Alkaline phosphatase	26.3% 10/38 • Number of events 19 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Alkalosis	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Anorexia	18.4% 7/38 • Number of events 8 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Ear and labyrinth disorders Auditory/Hearing-Other	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Bone pain	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Psychiatric disorders Confusion	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Eye disorders Conjunctivitis	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Constipation	34.2% 13/38 • Number of events 14 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Cough	23.7% 9/38 • Number of events 10 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Dehydration	18.4% 7/38 • Number of events 8 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Diarrhea (no colostomy)	28.9% 11/38 • Number of events 20 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders Dizziness/lightheadedness	15.8% 6/38 • Number of events 7 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia	23.7% 9/38 • Number of events 9 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Dyspnea	26.3% 10/38 • Number of events 13 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Ear, nose and throat examination abnormal	5.3% 2/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Edema	21.1% 8/38 • Number of events 13 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Edema limbs	5.3% 2/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Fatigue	57.9% 22/38 • Number of events 33 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Fever	5.3% 2/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Hand-and-foot syndrome	5.3% 2/38 • Number of events 5 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Skin and subcutaneous tissue disorders Hand-foot skin reaction	13.2% 5/38 • Number of events 7 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders Headache	13.2% 5/38 • Number of events 6 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Hemoglobin	52.6% 20/38 • Number of events 56 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Hemoglobin decreased	15.8% 6/38 • Number of events 6 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Hemoptysis	15.8% 6/38 • Number of events 8 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Injury, poisoning and procedural complications Hemorrhage-Other	10.5% 4/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hypercalcemia	7.9% 3/38 • Number of events 13 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hyperglycemia	60.5% 23/38 • Number of events 60 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hyperkalemia	23.7% 9/38 • Number of events 13 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hypoalbuminemia	52.6% 20/38 • Number of events 38 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hypocalcemia	50.0% 19/38 • Number of events 48 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hypoglycemia	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hypokalemia	28.9% 11/38 • Number of events 19 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Hyponatremia	47.4% 18/38 • Number of events 27 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Vascular disorders Hypotension	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Infections and infestations Infection without neutropenia	13.2% 5/38 • Number of events 5 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Joint pain	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Leukocytes (total WBC)	31.6% 12/38 • Number of events 33 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Leukopenia	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Lymphopenia	47.4% 18/38 • Number of events 46 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Psychiatric disorders Mood alteration-anxiety, agitation	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Psychiatric disorders Mood alteration-depression	10.5% 4/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Mucositis oral	7.9% 3/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Muscle weakness	5.3% 2/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Muscle weakness (not due to neuropathy)	18.4% 7/38 • Number of events 7 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Myalgia	10.5% 4/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.3% 2/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Nausea	42.1% 16/38 • Number of events 22 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders Neuropathy - motor	10.5% 4/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders Neuropathy-sensory	18.4% 7/38 • Number of events 9 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Neutrophils/granulocytes (ANC/AGC)	15.8% 6/38 • Number of events 8 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Oral pain	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Pain-Other	26.3% 10/38 • Number of events 15 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Cardiac disorders Palpitations	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Nervous system disorders Peripheral sensory neuropathy	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Platelet count decreased	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Platelets	15.8% 6/38 • Number of events 13 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Proctitis	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Skin and subcutaneous tissue disorders Rash desquamating	5.3% 2/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Skin and subcutaneous tissue disorders Rash/dermatitis	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
General disorders Rigors, chills	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations SGOT (AST) (serum glutamic oxaloacetic transaminase)	31.6% 12/38 • Number of events 20 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations SGPT (ALT) (serum glutamic pyruvic transaminase)	31.6% 12/38 • Number of events 18 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Salivary gland changes	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Cardiac disorders Sinus tachycardia	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Stomatitis/pharyngitis	34.2% 13/38 • Number of events 19 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Eye disorders Tearing (watery eyes)	7.9% 3/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	7.9% 3/38 • Number of events 4 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Voice alteration	7.9% 3/38 • Number of events 3 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Respiratory, thoracic and mediastinal disorders Voice changes/stridor/larynx	15.8% 6/38 • Number of events 7 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Gastrointestinal disorders Vomiting	13.2% 5/38 • Number of events 6 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Metabolism and nutrition disorders Weight loss	13.2% 5/38 • Number of events 5 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.
Investigations Wound-infectious	5.3% 2/38 • Number of events 2 • Adverse events were collected for all patients up to 30 days post treatment. Although 40 patients were enrolled, 2 patients withdrew consent after treatment started, therefore only 38 were included in toxicity analysis.

Additional Information

Dr. Francis Worden

University of Michigan Comprehensive Cancer Center

Phone: 734-936-0453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place