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Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Primary Purpose

Malignant Pleural Mesothelioma

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Carboplatin and Vinorelbine

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring Malignant Pleural Mesothelioma, Chemotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept. Oncol., Rigshospitalet

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Survival

Feasibility

Full Information

NCT ID

NCT00272558

First Posted

January 3, 2006

Last Updated

September 17, 2009

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00272558

Brief Title

Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Mesothelioma

Keywords

Malignant Pleural Mesothelioma, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Carboplatin and Vinorelbine

Primary Outcome Measure Information:

Title

Response

Secondary Outcome Measure Information:

Title

Survival

Title

Feasibility

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens B Sorensen, MD

Organizational Affiliation

Dept. Oncology, Rigshospitalet

Official's Role

Study Chair

Facility Information:

Facility Name

Dept. Oncol., Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

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Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

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