Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00145418|
Recruitment Status : Terminated (low enrollment)
First Posted : September 5, 2005
Results First Posted : January 31, 2013
Last Update Posted : June 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Oxaliplatin + Docetaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||March 2010|
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
- Response Rate [ Time Frame: Response is measured every 2 cycles until disease progression ]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 ]Progression is measured from each participants start of study until removal from treatment.
- Duration of Response [ Time Frame: 0 -12 months ]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 ]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.
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): NCT00145418
|United States, Illinois|
|Oncology Specialists, SC|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|