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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014