Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma
Phase 2
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Malignant Pleural Mesothelioma
Both
Malignant Pleural Mesothelioma
Trial Information
Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Principal Investigator
Jens B Sorensen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dept. Oncology, Rigshospitalet
Authority:
Denmark: National Board of Health
Study ID:
MPM phase II Carbo/VNB
NCT ID:
NCT00272558
Start Date:
September 2004
Completion Date:
September 2009
Related Keywords:
- Malignant Pleural Mesothelioma
- Malignant Pleural Mesothelioma
- Chemotherapy
- Mesothelioma
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