SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005862
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Sarcoma Drug: semaxanib Phase 2

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2000
Actual Primary Completion Date : July 2004

Arm Intervention/treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005862

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00005862     History of Changes
Other Study ID Numbers: CDR0000067893
First Posted: February 12, 2004    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: April 2002

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
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action