Clinical trial · Interventional
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas
NCT00005862CI-TRIAL-00009402completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| semaxanib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: semaxanib
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.