GILT Docetaxel - Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00174629|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 7, 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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms||Drug: Docetaxel/DDP Drug: docetaxel/gemcitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||449 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||January 2007|
|Experimental: 1||Drug: docetaxel/gemcitabine|
|Active Comparator: 2||Drug: Docetaxel/DDP|
- Overall response rate (complete plus partial responses) between the genotypic group and the control group using an intent-to-treat analysis.
- Time to treatment failure and survival [ Time Frame: calculated from the registration date until progression or death, respectively ]
- Clinical and laboratory toxicities graded according to NCIC-CTG Expanded Common Toxicity Criteria. [ Time Frame: before each cycle ]
- 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 ]
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): NCT00174629
|Study Director:||Jean-Philippe Aussel||Sanofi|