Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas
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.
Primary Purpose: Treatment
Robert N. Taub, MD, PhD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|