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Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

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.

Tracking Information
First Received DateJanuary 3, 2006
Last Changed DateSeptember 17, 2009
Start DateSeptember 2004
Actual Primary Completion DateSeptember 2009
Primary Outcome Measures

Response

Secondary Outcome Measures

Survival

Feasibility

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Drug: Carboplatin and Vinorelbine
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.

Recruitment Information
Recruitment StatusCompleted
Anticipated Enrollment40
GenderAll
Ages18 Years - 85 Years
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT00272558
SponsorRigshospitalet, Denmark
Verification DateSeptember 2009
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