Malignant Mesothelioma Clinical Trial
Official title:
Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating
patients with malignant mesothelioma of the pleura that cannot be removed by surgery.
OBJECTIVES: I. Estimate overall survival and confirmed and unconfirmed complete and partial
response in patients with unresectable malignant mesothelioma of the pleura treated with
gemcitabine plus cisplatin. II. Evaluate the qualitative and quantitative toxicities of this
regimen in this patient population.
OUTLINE: Patients receive gemcitabine IV over 30 minutes, immediately followed by cisplatin
IV over 30 minutes on days 1, 8, and 15. Courses are repeated every 28 days. Treatment
continues in the absence of unacceptable toxicity or disease progression. Patients with a
complete response receive 2 additional courses of therapy. Patients are followed every 6
months until death.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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