We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00272558
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : September 18, 2009
Information provided by:

January 3, 2006
January 6, 2006
September 18, 2009
September 2004
September 2009   (Final data collection date for primary outcome measure)
Same as current
Complete list of historical versions of study NCT00272558 on ClinicalTrials.gov Archive Site
  • Survival
  • Feasibility
Same as current
Not Provided
Not Provided
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma
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.

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Pleural Mesothelioma
Drug: Carboplatin and Vinorelbine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
MPM phase II Carbo/VNB
Not Provided
Not Provided
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Study Chair: Jens B Sorensen, MD Dept. Oncology, Rigshospitalet
Rigshospitalet, Denmark
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP