Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Malignant Pleural Mesothelioma

Treatments: Drug: Carboplatin and Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT00272558

MPM phase II Carbo/VNB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)