SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005862
First received: June 2, 2000
Last updated: February 8, 2013
Last verified: April 2002
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor Sarcoma |
Drug: semaxanib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Enrollment: | 60 |
| Study Start Date: | October 2000 |
| Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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 |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005862
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Investigators
| Study Chair: | George D. Demetri, MD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005862 History of Changes |
| Other Study ID Numbers: | CDR0000067893, DFCI-00002, NCI-330 |
| Study First Received: | June 2, 2000 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma gastrointestinal stromal tumor stage IV adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Sarcoma Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type SU 5416 |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013