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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005862 |
RATIONALE: SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas.
Condition | Intervention | Phase |
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Gastrointestinal Stromal Tumor Sarcoma |
Drug: semaxanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas |
Study Start Date: | October 2000 |
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.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 Hematopoietic: 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 Hepatic: 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 Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: 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 Pulmonary: No history of pulmonary embolism in past 3 months Other: 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: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery) Other: No concurrent antiinflammatory drugs
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 |
Study Chair: | George D. Demetri, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000067893, DFCI-00002, NCI-330 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005862 History of Changes |
Health Authority: | United States: Federal Government |
stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma gastrointestinal stromal tumor stage IV adult soft tissue sarcoma |
Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors SU 5416 Recurrence |
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Digestive System Diseases Neoplasms by Site |
Digestive System Neoplasms Gastrointestinal Diseases Sarcoma Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |