SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
Gastrointestinal Stromal Tumor, Sarcoma
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue sarcoma or gastrointestinal stromal tumor Measurable disease defined as lesions that can be measured in at least one dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan Must have received prior chemotherapy with no response or progression after initial response Evidence of disease progression in past 3 months No CNS metastases or primary brain tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks WBC greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Fibrin split products no greater than 0.001 mg Fibrinogen greater than 200 mg/dL Bilirubin no greater than upper limit of normal (ULN) AST/ALT less than 1.5 times ULN PT/PTT less than 1.25 times ULN Creatinine no greater than 1.5 mg/dL At least 1 year since bypass surgery for atherosclerotic coronary artery disease No uncompensated coronary artery disease No history of myocardial infarction or unstable/severe angina in past 6 months No severe peripheral vascular disease No history of deep venous or arterial thrombosis in past 3 months No history of pulmonary embolism in past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No diabetes mellitus No history of bleeding diathesis No known active retroviral disease No AIDS-associated Kaposi's sarcoma No history of allergic reaction to Cremophor or paclitaxel No uncontrolled illness or psychiatric disorder that would preclude study PRIOR CONCURRENT THERAPY: No concurrent immunotherapy At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No concurrent chemotherapy At least 3 weeks since prior radiotherapy No concurrent radiotherapy Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery) No concurrent antiinflammatory drugs
Sites / Locations
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Experimental
Arm I
atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.