A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas
semaxanib
Digestive System Diseases+7
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: October 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Massachusetts General Hospital Cancer Center
Boston, United StatesOpen Massachusetts General Hospital Cancer Center in Google MapsDana-Farber Cancer Institute
Boston, United States