GILT Docetaxel - Non-Small Cell Lung Cancer
This study has been completed.
Information provided by:
First received: September 9, 2005
Last updated: December 4, 2009
Last verified: December 2009
- To compare response rate between genotypic groups and control group.
- To determine the safety, time to treatment failure and survival in control and genotypic arms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Cooperative, Randomized, Multicenter Phase III Study on the Use of Cisplatin Resistant Genotype (ERCC1 Over-Expression) in Tumor RNA to Customize Chemotherapy in Stage IV-IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer Patients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
Secondary Outcome Measures:
- Time to treatment failure and survival [ Time Frame: calculated from the registration date until progression or death, respectively ] [ Designated as safety issue: No ]
- Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria. [ Time Frame: before each cycle ] [ Designated as safety issue: No ]
- Adverse events not reported in NCIC-CTG Expanded Common Toxicity Criteria will be graded as mild, moderate, severe, and life threatening. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2001|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|Experimental: 1||Drug: docetaxel/gemcitabine|
|Active Comparator: 2||Drug: Docetaxel/DDP|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174629
Sponsors and Collaborators
|Study Director:||Jean-Philippe Aussel||Sanofi|