NCT00003718

Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma

Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.

Detailed description

OBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population. OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Conditions

• Endometrial Cancer
• Ovarian Cancer
• Sarcoma

Interventions

Type	Name	Description
DRUG	temozolomide

Timeline

• Start date: 1998-09-01
• First posted: 2004-04-14
• Last updated: 2014-01-06

Locations

1 site across 1 country: United States