Evaluation of Activity and Toxicity of Polychemotherapy With 2-Drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer
Four treatment arms are planned.
- GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 & 8, every 21 days
- GEMCAR: gemcitabine 1000 on days 1 & 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1,
every 21 days
- GEMCIS: gemcitabine 1000 mg/m2 on days 1 & 8 and cisplatin 50 or 60 or 70 mg/m2 on day
1, every 21 days
- GEMETO: gemcitabine 1000 mg/m2 on days 1 & 8 and etoposide 60 or 70 or 80 mg/m2 on
days 1,2,3 every 21 days
For the study of the GEMVIN combination a two-stage minimax flexible design will be applied.
For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at
looking for optimal dose within a Bayesian framework will be applied.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
to evaluate activity and toxicity of GEMVIN combination
Cesare Gridelli, M.D.
Principal Investigator
San Giuseppe Moscati Hospital, Avellino, Italy
Italy: Ethics Committee
G-Step
NCT00401609
November 2000
February 2009
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