Phase II Multicenter Study Evaluating the Efficacy of Carboplatin-Etoposide Combination in Hormone-resistant Prostate Cancers With Neuroendocrine Differentiation.
Neuro-endocrine differentiation is observed in the evolution of hormone-resistant prostate
cancer. The aim of our study is to assess the efficacy and toxicity of a chemotherapy
regimen combining carboplatin and etoposide in patients with metastatic hormone-resistant
prostate cancer and neuro-endocrine differentiation. To be eligible, patients must have
either circulating neuro-endocrine markers (Chromogranin A: CgA, Neuron Specific Enolase:
NSE)and/or visceral metastases. Eligible patients are treated with the combination of
carboplatin AUC4 administered on day 1 and etoposide 100 mg/m2 given on day 1, day 2 and day
3 and repeated every 3 weeks for a maximum of 6 cycles. The primary objective of the study
is to assess objective response to the carboplatin - etoposide combination (according to
RECIST criteria for lesions and defined as a 50% or greater decrease from baseline serum
values for PSA and neuro-endocrine markers). Secondary objectives include evaluation of
toxicity, duration of response, progression-free-survival and overall survival.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (clinical and/or biological): Clinical: objective response of target lesions according to RECIST criteria Biological: greater than 50% decrease of PSA, NSE and Chromogranin A levels
Every 6 weeks during treatment (6 cycles of carboplatin-etoposide) and 3 to 4 weeks after the end of treatment
No
FLECHON Aude, MD
Principal Investigator
Centre Leon Berard
France: Direction Générale de la Santé
CARBETOP
NCT00973882
April 2005
January 2010
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