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Posted on Saturday, Mar 1, 2008

Study of Carboplatin and Vinorelbine in 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…

Date First Received: January 3, 2006

Last Updated: September 8, 2006

Verified by: Rigshospitalet, Denmark, September 2006

Clinical Trial Phase: Phase 2 Start Date: September 2004

Overall Status: Recruiting

Estimated Enrollment: 40
Brief Summary

Official Title: “Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma.”

Condition Keyword(s):

  • Malignant Pleural Mesothelioma

Intervention(s):

  • Drug: Carboplatin and Vinorelbine

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy StudyDetailed

Clinical Trial 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.Outcome Measures for this Clinical Trial

Primary:

  • Response

Secondary:

  • Survival
  • Feasibility

Criteria for Participation in this Clinical Trial

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Rigshospitalet, Denmark

Dept. Oncol., Rigshospitalet

Copenhagen 2100 Denmark

Overall Clinical Trial Officials and Contacts

Jens B Sorensen, MD Study Chair Dept. Oncology, Rigshospitalet

Overall Contact: Jens B. Sorensen, MD 35454392 jbsonk@rh.dk

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272558

Study ID Number: MPM phase II Carbo/VNB

ClinicalTrials.gov Identifier: NCT00272558

Health Authority: Denmark: National Board of HealthClinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

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Nancy Meredith is a blog and web content writer with more than 20 years of professional experience in the Information Technology industry. She has been writing about Mesothelioma for 4 years. Follow Nancy on Google+