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

NCT ID: NCT00005862

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31

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.

Conditions

Gastrointestinal Stromal Tumor; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

semaxanib

Intervention Type: DRUG

Interventions

semaxanib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George D. Demetri, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

DFCI-00002

Identifier Type: -

Identifier Source: secondary_id

NCI-330

Identifier Type: -

Identifier Source: secondary_id

CDR0000067893

Identifier Type: -

Identifier Source: org_study_id