Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma (NCT00003718) | Clinical Trial Compass
UnknownPhase 2
Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
United States25 participantsStarted 1998-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS: Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination No CNS metastases No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Calcium less than ULN Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission No nonmalignant systemic disease rendering patient a poor medical risk No acute infection requiring IV antibiotics HIV negative No AIDS-related illness No frequent vomiting or medical condition tha…