Malignant Mesothelioma Clinical Trial
Official title:
Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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