Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

This study has been completed.

First Received: January 3, 2006 Last Updated: September 17, 2009 History of Changes

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00272558

Purpose

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 II

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

MedlinePlus related topics: Mesothelioma

Drug Information available for: Carboplatin Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	MPM phase II Carbo/VNB
Study First Received:	January 3, 2006
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00272558 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:

Malignant Pleural Mesothelioma
Chemotherapy

Additional relevant MeSH terms:

Neoplasms
Vinorelbine
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses

Mesothelioma
Carboplatin
Antineoplastic Agents, Phytogenic
Adenoma
Pharmacologic Actions
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009