Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer.
Approximately 54 subjects will take part in this study.
Carcinoma of the Head and Neck
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck|
- Tumor Response [ Time Frame: 6 months after the last subject enrolled has gone off study ] [ Designated as safety issue: No ]
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.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: At end of every cycle ] [ Designated as safety issue: Yes ]Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|Study Start Date:||September 2004|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
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.
Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.Drug: Oxaliplatin
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Barbara Gitlitz, MD||University of Southern California|