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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Tumor Response
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.
Time frame: 6 months after the last subject enrolled has gone off study
Number of Participants With Serious Adverse Events (SAEs)
Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: At end of every cycle
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