Clinical trial NCT00005862: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: George D. Demetri, MD
role: STUDY_CHAIR
References: