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

June 2, 2000
February 8, 2013
October 2000
July 2004   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00005862 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Stromal Tumor
  • Sarcoma
Drug: semaxanib
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.
Intervention: Drug: semaxanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
July 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005862
CDR0000067893, DFCI-00002, NCI-330
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
National Cancer Institute (NCI)
April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP