Trial Outcomes & Findings for Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer (NCT NCT00871169)

Last Updated: 2016-06-14

Results Overview

ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

2 years

Results posted on

2016-06-14

Participant Flow

Subjects were recruited at the University of New Mexico Comprehensive Cancer Center between October, 2008, and December, 2014.

Participant milestones

Participant milestones
Measure	Irinotecan, Oxaliplatin, and Cetuximab The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Overall Study STARTED	61
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Irinotecan, Oxaliplatin, and Cetuximab The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Overall Study Protocol Violation	1
Overall Study Patient did not receive study treatment	2

Baseline Characteristics

Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Irinotecan, Oxaliplatin, and Cetuximab n=58 Participants The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Age, Continuous	62 years n=39 Participants
Sex: Female, Male Female	27 Participants n=39 Participants
Sex: Female, Male Male	31 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Region of Enrollment United States	58 participants n=39 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Irinotecan, Oxaliplatin, and Cetuximab n=58 Participants The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Overall Response Rate (ORR)	6.9 percentage of participants Interval 1.91 to 16.7

SECONDARY outcome

Timeframe: 2 years

Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events, and Serious Adverse Events (SAEs)).

Outcome measures

Outcome measures
Measure	Irinotecan, Oxaliplatin, and Cetuximab n=58 Participants The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Toxicity Grade 3 Hyperglycemia	6 participants
Toxicity Grade 3 Hypoalbuminemia	1 participants
Toxicity Grade 3 Pain - Bone	1 participants
Toxicity Grade 4 Hypothermia	1 participants
Toxicity Grade 4 Pleural Effusion	1 participants
Toxicity Grade 3 Alkaline Phosphatase Increased	4 participants
Toxicity Grade 3 Allergic Reaction/Hypersensitivity	1 participants
Toxicity Grade 3 Anorexia	2 participants
Toxicity Grade 3 Ascites	2 participants
Toxicity Grade 3 Aspartate Aminotransferase Increased	1 participants
Toxicity Grade 3 Constipation	3 participants
Toxicity Grade 3 Creatinine Increased	1 participants
Toxicity Grade 3 Hemoglobin Decreased	2 participants
Toxicity Grade 3 Dehydration	1 participants
Toxicity Grade 3 Diarrhea	1 participants
Toxicity Grade 3 Limb Edema	1 participants
Toxicity Grade 3 Fatigue	8 participants
Toxicity Grade 3 Gamma-glutamyltransferase Increased	2 participants
Toxicity Grade 3 Hyperbilirubinemia	3 participants
Toxicity Grade 3 Hypokalemia	11 participants
Toxicity Grade 3 Hyponatremia	1 participants
Toxicity Grade 3 Hypophosphatemia	3 participants
Toxicity Grade 3 Insomnia	1 participants
Toxicity Grade 3 Leukopenia	1 participants
Toxicity Grade 3 Nausea	3 participants
Toxicity Grade 3 Neutropenia	3 participants
Toxicity Grade 3 Pain - Abdomen	5 participants
Toxicity Grade 3 Decreased Respiration	1 participants
Toxicity Grade 3 Rash	3 participants
Toxicity Grade 3 Syncope	1 participants
Toxicity Grade 3 Thrombocytopenia	2 participants
Toxicity Grade 3 Vomiting	2 participants
Toxicity Grade 4 Encephalopathy	1 participants
Toxicity Grade 4 Fatigue	1 participants
Toxicity Grade 4 Gamma-glutamyltransferase Increased	1 participants
Toxicity Grade 4 Hyperglycemia	1 participants
Toxicity Grade 4 Hypokalemia	1 participants
Toxicity SAE: Grade 3 Acidosis	1 participants
Toxicity SAE: Grade 3 Anorexia	1 participants
Toxicity SAE: Grade 3 Ascites	1 participants
Toxicity SAE: Grade 3 Bacteremia	1 participants
Toxicity SAE: Grade 3 Cholangitis	1 participants
Toxicity SAE: Grade 3 Dehydration	7 participants
Toxicity SAE: Grade 3 Diarrhea	1 participants
Toxicity SAE: Grade 3 Fatigue	1 participants
Toxicity SAE: Grade 3 Gastrointestinal Hemorrhage	2 participants
Toxicity SAE: Grade 4 Hyperbilirubinemai	1 participants
Toxicity SAE: Grade 4 Hyperglycemia	1 participants
Toxicity SAE: Grade 3 Hypotension	1 participants
Toxicity SAE: Grade 2 Bowel Obstruction	1 participants
Toxicity SAE: Grade 3 Bowel Obstruction	2 participants
Toxicity SAE: Grade 3 Gholangitis	1 participants
Toxicity SAE: Grade 2 Urinary Tract Infection	1 participants
Toxicity SAE: Grade 3 Infection of unknown origin	1 participants
Toxicity SAE: Grade 5 Intracranial Hemorrhage	1 participants
Toxicity SAE: Grade 2 Mental Status Change	1 participants
Toxicity SAE: Grade 4 Muscle Weakness	1 participants
Toxicity SAE: Grade 3 Nausea	1 participants
Toxicity SAE: Grade 2 Abdominal Pain	1 participants
Toxicity SAE: Grade 3 Abdominal Pain	4 participants
Toxicity SAE: Grade 2 Pulmonary embolus	1 participants
Toxicity SAE: Grade 4 Pulmonary Embolus	2 participants
Toxicity SAE: Grade 4 Renal Failure	1 participants
Toxicity SAE: Grade 4 Seizure	1 participants
Toxicity SAE: Grade 2 Sinus tachycardia	1 participants
Toxicity SAE: Grade 4 Thrombosis	1 participants
Toxicity SAE: Grade 3 Vomiting	3 participants
Toxicity SAE: Grade 3 Weight Loss	1 participants

Adverse Events

Irinotecan, Oxaliplatin, and Cetuximab

Serious events: 24 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Irinotecan, Oxaliplatin, and Cetuximab n=58 participants at risk The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Metabolism and nutrition disorders Acidosis	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Anorexia	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Ascites	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Infections and infestations Bacteremia	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Infections and infestations Cholangitis (Biliary tract infection)	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Dehydration	8.6% 5/58 • Number of events 7 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Diarrhea	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Fatigue	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Vascular disorders Hemorrhage - Gastrointestinal	1.7% 1/58 • Number of events 2 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hyperbilirubinemia (Elevated bilirubin)	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hyperglycemia (High blood glucose)	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Cardiac disorders Hypotension	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Ileus (bowel obstruction)	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Infections and infestations Infection - biliary tract (cholangitis)	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Infections and infestations Infection - Urinary tract	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Infections and infestations Infection of unknown origin	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Vascular disorders Intracranial hemorrhage	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Psychiatric disorders Mental status changes	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Nausea	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Pain - Abdomen	8.6% 5/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Vascular disorders Pulmonary Emboli	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Renal and urinary disorders Renal failure	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Psychiatric disorders Seizure	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Cardiac disorders Sinus tachycardia	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Vascular disorders Thrombosis/embolism (vascular access)	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Vomiting	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Weight loss	1.7% 1/58 • Number of events 1 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.

Other adverse events

Other adverse events
Measure	Irinotecan, Oxaliplatin, and Cetuximab n=58 participants at risk The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.
Gastrointestinal disorders Abdominal distention	8.6% 5/58 • Number of events 6 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Skin and subcutaneous tissue disorders Acneiform rash	8.6% 5/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Alanine aminotransferase increased	6.9% 4/58 • Number of events 6 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Alkaline phosphatase increased	19.0% 11/58 • Number of events 14 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Skin and subcutaneous tissue disorders Alopecia	15.5% 9/58 • Number of events 11 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Blood and lymphatic system disorders Anemia	6.9% 4/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Anorexia	37.9% 22/58 • Number of events 27 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Nervous system disorders Anxiety	6.9% 4/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Ascites	6.9% 4/58 • Number of events 6 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Aspartate aminotransferase increased	8.6% 5/58 • Number of events 6 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Constipation	31.0% 18/58 • Number of events 23 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 3/58 • Number of events 4 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Blood and lymphatic system disorders Decreased hemoglobin	19.0% 11/58 • Number of events 18 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Dehydration	10.3% 6/58 • Number of events 6 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Nervous system disorders Depression	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Diarrhea	46.6% 27/58 • Number of events 43 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Nervous system disorders Dizziness	8.6% 5/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Skin and subcutaneous tissue disorders Dry skin	15.5% 9/58 • Number of events 9 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Dyspepsia (Heartburn)	8.6% 5/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Respiratory, thoracic and mediastinal disorders Dyspnea (Shortness of breath)	8.6% 5/58 • Number of events 5 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Edema - limbs	15.5% 9/58 • Number of events 10 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Fatigue	50.0% 29/58 • Number of events 53 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Fever	10.3% 6/58 • Number of events 9 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Gamma-glutamyltransferase increased	13.8% 8/58 • Number of events 11 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Vascular disorders Hemorrhage - Nasal	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hyperbilirubinemia (High bilirubin levels)	10.3% 6/58 • Number of events 9 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hyperglycemia (High glucose levels)	20.7% 12/58 • Number of events 25 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hypoalbuminemia (Low blood albumin)	20.7% 12/58 • Number of events 18 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hypocalcemia (Low calcium levels)	17.2% 10/58 • Number of events 12 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hypokalemia (Low potassium levels)	29.3% 17/58 • Number of events 35 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hypomagnesemia (Low magnesium levels)	12.1% 7/58 • Number of events 11 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hyponatremia (Low sodium levels)	10.3% 6/58 • Number of events 8 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Metabolism and nutrition disorders Hypophosphatemia (Low phosphate levels)	6.9% 4/58 • Number of events 10 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Infections and infestations Infection - Urinary tract	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Nervous system disorders Insomnia	13.8% 8/58 • Number of events 10 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Blood and lymphatic system disorders Leukopenia (Decreased leukocytes)	10.3% 6/58 • Number of events 10 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Mucositis	10.3% 6/58 • Number of events 7 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Nausea	58.6% 34/58 • Number of events 56 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Blood and lymphatic system disorders Neutropenia (Decreased neutrophils)	27.6% 16/58 • Number of events 24 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Pain - Abdomen	32.8% 19/58 • Number of events 32 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Pain - Back	5.2% 3/58 • Number of events 3 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Nervous system disorders Peripheral sensory neuropathy	27.6% 16/58 • Number of events 22 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Skin and subcutaneous tissue disorders Pruritis (Itching)	6.9% 4/58 • Number of events 4 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Skin and subcutaneous tissue disorders Rash	51.7% 30/58 • Number of events 44 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Rigors/chills	6.9% 4/58 • Number of events 4 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Taste alteration	10.3% 6/58 • Number of events 7 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Blood and lymphatic system disorders Thrombocytopenia (decreased platelets)	13.8% 8/58 • Number of events 14 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Gastrointestinal disorders Vomiting	41.4% 24/58 • Number of events 40 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
General disorders Weight loss	34.5% 20/58 • Number of events 25 Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.

Additional Information

Fa-chyi Lee, MD

University of New Mexico Comprehensive Cancer Center

Phone: 505-925-0405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place