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A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumor, Sarcoma

Thank you

Trial Information

A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

George D. Demetri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067893

NCT ID:

NCT00005862

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • gastrointestinal stromal tumor
  • stage IV adult soft tissue sarcoma
  • Gastrointestinal Stromal Tumors
  • Sarcoma

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115