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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Gastrointestinal Stromal Tumor

Treatments

Drug: semaxanib

Study type

Interventional

Funder types

NIH

Identifiers

NCT00005862

CDR0000067893

DFCI-00002

NCI-330

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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