Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Phase 2

Completed

• Conditions: Malignant Pleural Mesothelioma

• Registration Number: NCT00272558
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Study First Posted: 2006-01-06
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically verified malignant pleural Mesothelioma
• Age above 18 years
• Performance status 0-2

Exclusion Criteria

• No previous chemotherapy
• Normal renal, liver and bone marrow function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response

Secondary Outcome Measures

Name	Time	Method
Survival
Feasibility

Trial Locations

Locations (1)

Dept. Oncol., Rigshospitalet; 🇩🇰 Copenhagen, Denmark