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

Primary Purpose

Gastrointestinal Stromal Tumor, Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
semaxanib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005862
Brief Title
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
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 Type
Interventional

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor, Sarcoma
Keywords
stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
semaxanib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George D. Demetri, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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

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