Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

This study has been completed.
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: January 3, 2006
Last updated: September 17, 2009
Last verified: September 2009

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.

Condition Intervention Phase
Malignant Pleural Mesothelioma
Drug: Carboplatin and Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Response

Secondary Outcome Measures:
  • Survival
  • Feasibility

Estimated Enrollment: 40
Study Start Date: September 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00272558

Dept. Oncol., Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Jens B Sorensen, MD Dept. Oncology, Rigshospitalet
  More Information

No publications provided Identifier: NCT00272558     History of Changes
Other Study ID Numbers: MPM phase II Carbo/VNB
Study First Received: January 3, 2006
Last Updated: September 17, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Malignant Pleural Mesothelioma

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 22, 2014