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NCT00272558 Clinical Trial

Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Malignant Pleural Mesothelioma Clinical Trial

Official title:
Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00272558
Other study ID # MPM phase II Carbo/VNB
Secondary ID
Status Completed
Phase Phase 2
First received January 3, 2006
Last updated September 17, 2009
Start date September 2004
Est. completion date September 2009

Study information
Verified date September 2009
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Carboplatin and Vinorelbine

Locations
Country Name City State
Denmark Dept. Oncol., Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response
Secondary Survival
Secondary Feasibility
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