Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma - Full Text View

Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, May 2008

Sponsored by:	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 intraveneous in advanced pleural mesothelioma.

Condition	Intervention	Phase
Malignant Pleural Mesothelioma	Drug: Carboplatin and Vinorelbine	Phase II

MedlinePlus related topics:

Mesothelioma

ChemIDplus related topics:

Carboplatin Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

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.

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
Estimated Study Completion Date:	January 2007

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

Contacts


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

Locations


Denmark
	Dept. Oncol., Rigshospitalet	Recruiting
	Copenhagen, Denmark, 2100
	Contact: Jens B. Sorensen, MD 35454392 jbsonk@rh.dk
	Contact: Jens B. Sorensen, MD 35454392 jbsonk@rh.dk
	Principal Investigator: Jens B. Sorensen, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators


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

More Information

Study ID Numbers:	MPM phase II Carbo/VNB
First Received:	January 3, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00272558
Health Authority:	Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:

Malignant Pleural Mesothelioma

Chemotherapy

Study placed in the following topic categories:

Vinorelbine

Mesothelioma

Carboplatin

Adenoma

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Antineoplastic Agents

Neoplasms, Mesothelial

Therapeutic Uses

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008