Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2006

Last Updated Date

September 17, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00272558 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival
Feasibility

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Official Title ^ICMJE

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

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Malignant Pleural Mesothelioma

Intervention ^ICMJE

Drug: Carboplatin and Vinorelbine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00272558

Responsible Party

Study ID Numbers ^ICMJE

MPM phase II Carbo/VNB

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Jens B Sorensen, MD

Dept. Oncology, Rigshospitalet

Information Provided By

Rigshospitalet, Denmark

Verification Date

September 2009

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