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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.