Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00272558
First received: January 3, 2006
Last updated: September 17, 2009
Last verified: September 2009

January 3, 2006
September 17, 2009
September 2004
September 2009   (final data collection date for primary outcome measure)
Response
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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Completed
40
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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00272558
MPM phase II Carbo/VNB
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