Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT00272558
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.7

Study Details

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
• Anticipated 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: Sep 1, 2004
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Outcome Measures

Primary Outcome Measures

1. Response []

Secondary Outcome Measures

1. Survival []

2. Feasibility []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dept. Oncol., Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00272558
• Other Study ID Numbers: MPM phase II Carbo/VNB
• First Posted: Jan 6, 2006
• Last Update Posted: Sep 18, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Malignant Pleural Mesothelioma; Chemotherapy
• Additional relevant MeSH terms: Mesothelioma; Mesothelioma, Malignant; Carboplatin; Vinorelbine

Study Results

No Results Posted as of Sep 18, 2009