SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: I. Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416. II. Determine the safety of SU5416 in these patients. OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 1 year.

Official Title
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A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas

Conditions
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Gastrointestinal Stromal Tumor, Sarcoma

Intervention / Treatment
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* Drug: semaxanib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. | Drug: semaxanib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma