Trial Information

Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With 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.