SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas (NCT00005862) | Clinical Trial Compass
CompletedPhase 2
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
United States60 participantsStarted 2000-10
Plain-language summary
Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 re…