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SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
This study has been completed.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005862
  Purpose

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
Gastrointestinal Stromal Tumor
Sarcoma
Drug: semaxanib
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Semaxanib SU 5416
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
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.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

  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 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

  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
Dana-Farber Cancer Institute
Investigators
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009