S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma|
- Estimate overall survival [ Time Frame: monthly while patient on treatment. Once off treatment every 6 months ] [ Designated as safety issue: No ]
- qualitative and quantitative toxicities [ Time Frame: week 1, 2, 3 (q 28 days) ] [ Designated as safety issue: Yes ]
- confirmed and unconfirmed complete and partial response [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
|Study Start Date:||February 1999|
|Study Completion Date:||December 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days) cisplatin 30 mg/m^2 days 1, 8, 15 (q 28 days)
Drug: gemcitabine hydrochloride
Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days)
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.