RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma. PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have...
Date First Received: February 14, 2002
Last Updated: February 9, 2008
Verified by: National Cancer Institute (NCI), May 2003
Clinical Trial Phase: Phase 2 | Start Date: November 2000
Overall Status: Active, not recruiting
Brief Summary
Official Title: “Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma”
Condition Keyword(s):
RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably.
It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma.
PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Detailed Clinical Trial Description
OBJECTIVES: - Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin, vinblastine, and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma. - Determine the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms. - Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques). - Arm II: Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV (courses 1, 2, and 4 only), vinblastine IV, and cisplatin IV over 4 hours on day 1. Chemotherapy repeats every 21 days for a total of 4 courses. - Arm III: Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14.
Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.
Criteria for Participation in this Clinical Trial
DISEASE CHARACTERISTICS:
- Immunohistochemically or cytologically confirmed malignant mesothelioma
- Epithelial and other histological types
- Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy
- Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm3
- Neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Considered medically fit to receive chemotherapy
- No other disease or prior malignancy that would preclude study
- No clinical evidence of infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for mesothelioma
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: British Thoracic Society
Dorothy House Foundation
Bradford-Onavon BA15 2LE United Kingdom
St. Peters Hospital
Chertsey Surrey KT 16 OPZ United Kingdom
Leeds Teaching Hospital Trust
Leeds England LS1 3EX United Kingdom
Medical Research Council Clinical Trials Unit
London England NW1 2DA United Kingdom
Princess Royal Hospital
Hull England HU8 9HE United Kingdom
Royal Marsden Hospital
Sutton England SM2 5PT United Kingdom
Saint Bartholomew's Hospital
London England EC1A 7BE United Kingdom
Aberdeen Royal Infirmary
Aberdeen Scotland AB25 2ZN United Kingdom
Stobhill General Hospital
Glasgow Scotland G21 3UW United Kingdom
Overall Clinical Trial Officials and Contacts
Martin F. Muers, MD Study Chair Leeds General Infirmary
Additional Information
Information obtained from ClinicalTrials.gov on May 08, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00030459
Study ID Number: CDR0000069167
ClinicalTrials.gov Identifier: NCT00030459
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
