S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed soft tissue sarcoma of 1 of the following histologies:

• Angiosarcoma, cutaneous or visceral

• Malignant hemangiosarcoma

• Malignant hemangiopericytoma

• Grade 3-4 leiomyosarcoma

• Grade 3-4 liposarcoma

• Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography

• Measurable disease by x-ray, scans, or physical examination

• Archived paraffin-embedded tumor sections available

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)

• Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)

• PT, PTT, and INR normal

Renal

• Creatinine normal OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No history of thromboembolic disease

• No uncontrolled hypertension

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Able to swallow oral medication

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered

• Prior adjuvant chemotherapy allowed

• No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• At least 28 days since prior radiotherapy and recovered

• Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy

Surgery

• At least 28 days since prior major surgery and recovered

Other

• No prior sorafenib

• No prior inhibitor of VEGFR or MAPK pathway

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No concurrent therapeutic anticoagulation

• No concurrent administration of any of the following medications:

• Rifampin

• Hypericum perforatum (St. John's wort)

• Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:

• Phenytoin

• Carbamazepine

• Phenobarbital