Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00030459|
Recruitment Status : Unknown
Verified May 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: cisplatin Drug: mitomycin C Drug: vinblastine sulfate Drug: vinorelbine tartrate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma|
|Study Start Date :||November 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030459
|Princess Royal Hospital|
|Hull, England, United Kingdom, HU8 9HE|
|Leeds Teaching Hospital Trust|
|Leeds, England, United Kingdom, LS1 3EX|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Medical Research Council Clinical Trials Unit|
|London, England, United Kingdom, NW1 2DA|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Stobhill General Hospital|
|Glasgow, Scotland, United Kingdom, G21 3UW|
|Dorothy House Foundation|
|Bradford-Onavon, United Kingdom, BA15 2LE|
|St. Peters Hospital|
|Chertsey Surrey, United Kingdom, KT 16 OPZ|
|Study Chair:||Martin F. Muers, MD||Leeds General Infirmary|
|Study Chair:||David J. Girling, MD||Medical Research Council|