Carboplatin-Etoposide Combination in Hormone-Resistant Prostate Cancers
NCT00973882 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2011-11-03
Summary
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. Eligible patients are treated with the combination of carboplatin AUC4 on day 1 and etoposide 100 mg/m2 on day 1, day 2 and day 3 repeated every 3 weeks for a maximum of 6 cycles. Efficacy endpoints include Prostate Specific Antigen (PSA) and neuro-endocrine marker response (defined as a 50% or greater decrease from baseline serum values), objective response rate (according to RECIST criteria), and toxicity.
Conditions
Interventions
- DRUG
-
Carboplatin AUC4 on day 1 repeated every 3 weeks for a maximum of 6 cycles
- DRUG
-
Etoposide
Etoposide 100 mg/m2 on day 1, day 2 and day 3 repeated every 3 weeks for a maximum of 6 cycles
Sponsors & Collaborators
-
Centre Leon Berard
lead OTHER
Principal Investigators
-
FLECHON Aude, MD · Centre Leon Berard
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2009-07-31
- Completion
- 2010-01-31
Countries
- France
Study Locations
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