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


    - General Info     - Purpose     - Eligibility     - Contacts & Locations     - Additional Information

Status: Recruiting
Sponsors and Collaborators: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
Government Identifier: NCT00272558

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

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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.
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.

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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

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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    

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Additional Information:

Study ID Numbers:   MPM phase II Carbo/VNB
First Received:   January 3, 2006
Last Updated:   September 8, 2006
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
Mesothelioma
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

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