Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00184028|
Recruitment Status : Terminated (Insufficient Accrual)
First Posted : September 16, 2005
Results First Posted : May 6, 2013
Last Update Posted : May 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of the Head and Neck||Drug: Taxotere Drug: Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2010|
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.
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
- Tumor Response [ Time Frame: 6 months after the last subject enrolled has gone off study ]
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 ]Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184028
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Barbara Gitlitz, MD||University of Southern California|