Trial Outcomes & Findings for Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck (NCT NCT00184028)

Last Updated: 2014-05-22

Results Overview

All eligible patients who received the first dose of Taxotere will be included in the analysis. Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease. Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

6 months after the last subject enrolled has gone off study

Results posted on

2014-05-22

Participant Flow

Participants were recruited at USC/Los Angeles County General Hospital and the USC/Norris Cancer Hopital between March 2005 and October 2007.

The trial had no pre-assignment criteria. All subjects were given the same treatment.

Participant milestones

Participant milestones
Measure	Taxotere Followed by Oxaliplatin On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Overall Study STARTED	12
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Taxotere Followed by Oxaliplatin On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Overall Study Death	1
Overall Study Lack of Efficacy	4
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1
Overall Study Non-compliance	2

Baseline Characteristics

Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Taxotere Followed by Oxaliplatin n=12 Participants On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 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	2 Participants n=99 Participants
Race (NIH/OMB) White	6 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	12 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months after the last subject enrolled has gone off study

Outcome measures

Outcome measures
Measure	Arm 1 n=12 Participants Single arm study
Tumor Response Complete Response	0 Participants
Tumor Response Partial Response	1 Participants
Tumor Response Stable Disease	5 Participants
Tumor Response Progressive Disease	2 Participants
Tumor Response Early Offstudy (refused further therapy)	3 Participants
Tumor Response Early Death (due to malignant disease)	1 Participants

SECONDARY outcome

Timeframe: At end of every cycle

Population: All participants who started treatment

Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	Arm 1 n=12 Participants Single arm study
Number of Participants With Serious Adverse Events (SAEs)	7 Participants

Adverse Events

Taxotere Followed by Oxaliplatin

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Taxotere Followed by Oxaliplatin n=12 participants at risk On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Anorexia	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
General disorders Death not associated with CTCAE term (Death NOS)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
General disorders Fatigue	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Blood and lymphatic system disorders Hemoglobin	8.3% 1/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Infections and infestations Infection (documented clinically or microbiologically)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Leukocytes (total WBC)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Psychiatric disorders Mood Alteration (Agitation)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Neutrophils/Granulocytes (ANC/AGC)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Phosphate, serum-low (Hypophosphatemia)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Potassium, serum-low (Hypokalemia)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Nervous system disorders Neuropathy: cranial (CN VII motor-face; sensory-taste)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.

Other adverse events

Other adverse events
Measure	Taxotere Followed by Oxaliplatin n=12 participants at risk On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Nervous system disorders Ataxia (incoordination)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Nervous system disorders Dizziness	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Gastrointestinal disorders Constipation	33.3% 4/12 • Number of events 4 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Vascular disorders Flushing	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	66.7% 8/12 • Number of events 10 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Blood and lymphatic system disorders Hemoglobin	75.0% 9/12 • Number of events 14 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Psychiatric disorders Insomnia	50.0% 6/12 • Number of events 6 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Nervous system disorders Taste alteration (dysgeusia)	33.3% 4/12 • Number of events 4 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Musculoskeletal and connective tissue disorders Pain (muscle)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Platelets	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Leukocytes (total WBC)	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Cardiac disorders Pain (cardiac/heart)	8.3% 1/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	33.3% 4/12 • Number of events 4 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	41.7% 5/12 • Number of events 6 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Nervous system disorders Pain (Head/headache)	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Nervous system disorders Neuropathy: Sensory	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Gastrointestinal disorders Pain (Abdomen NOS)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Dehydration	33.3% 4/12 • Number of events 4 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Ear and labyrinth disorders Hearing: patients without baseline audiogram and not enrolled in monitoring program	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Gastrointestinal disorders Heartburn/Dyspepsia	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Psychiatric disorders Mood Alteration (Anxiety)	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
General disorders Fever (in the absence of neutropenia)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Alkaline Phosphatase	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Psychiatric disorders Mood alteration (Agitation)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Psychiatric disorders Mood alteration (Depression)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Skin and subcutaneous tissue disorders Rash/desquamation	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Cardiac disorders Supraventricular and nodal arrythmia (Sinus tachycardia)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Musculoskeletal and connective tissue disorders Pain (neck)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Nervous system disorders Neuropathy: motor	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Gastrointestinal disorders Vomiting	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	16.7% 2/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	16.7% 2/12 • Number of events 4 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations INR (International Normalized Ratio of Prothrombin)	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations PTT (Partial Thromboplastin Time)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Calcium, serum-low (hypcalcemia)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Bicarbonate, serum-low	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	16.7% 2/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	16.7% 2/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Weight Loss	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
General disorders Fatigue (asthenia, lethargy, malaise)	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Ear and labyrinth disorders Pain (middle ear)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	25.0% 3/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Skin and subcutaneous tissue disorders Nail changes	16.7% 2/12 • Number of events 3 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Skin and subcutaneous tissue disorders Hyperpigmentation	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Gastrointestinal disorders Nausea	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Investigations Neutrophils/granulocytes (ANC/AGC)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils (Soft Tissue NOS)	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.

Additional Information

Barbara Gitlitz, MD

USC/Norris Comrpehensive Cancer Center

Phone: 323-865-3906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place