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

February 8, 2013 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimate)

February 12, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

April 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067893
  • DFCI-00002
  • NCI-330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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