Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and
docetaxel and to determine the response rate to this study drug combination. The primary
objective of the study is response rate by RECIST criteria. The secondary objective is time
to progression, duration of response, and toxicity. Patients will receive:
- oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
- docetaxel 30mg/m2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.
Response is measured every 2 cycles until disease progression
Chadi Nabhan, MD
Oncology Specialists, SC
United States: Institutional Review Board
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