NCT00003723

S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery

Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	Gemcitabine 1000 mg/m\^2 days 1, 8 15 (q 28 days)

Timeline

• Start date: 1999-02-01
• Primary completion: 2007-06-01
• Completion: 2007-12-01
• First posted: 2004-06-24
• Last updated: 2012-10-08

Locations

84 sites across 1 country: United States