Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.
Malignant Pleural Mesothelioma
Drug: Carboplatin and Vinorelbine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma|
|Study Start Date:||September 2004|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles.
Endpoint is response rate, secondary endpoints survival and toxicity.