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Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT00272558
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: Carboplatin and Vinorelbine Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2004
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Response

Secondary Outcome Measures :
  1. Survival
  2. Feasibility

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272558


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

ClinicalTrials.gov Identifier: NCT00272558     History of Changes
Other Study ID Numbers: MPM phase II Carbo/VNB
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Rigshospitalet, Denmark:
Malignant Pleural Mesothelioma
Chemotherapy

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Vinorelbine
Carboplatin
Vinblastine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action