Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Response Rate [ Time Frame: Response is measured every 2 cycles until disease progression ] [ Designated as safety issue: No ]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.
- Time to Progression [ Time Frame: <1 cycle to 6 cycles of treatment ] [ Designated as safety issue: No ]Progression is measured from each participants start of study until removal from treatment.
- Duration of Response [ Time Frame: 0 -12 months ] [ Designated as safety issue: No ]Duration of response is a measure of how long the participants response to therapy was maintained.
- Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. [ Time Frame: day one of cycle one until participant removed from trial ] [ Designated as safety issue: Yes ]Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.
|Study Start Date:||February 2005|
|Study Completion Date:||March 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC.
Drug: Oxaliplatin + Docetaxel
Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
Other Name: Eloxatin
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.
|United States, Illinois|
|Oncology Specialists, SC|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|