S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas | NCT00217620 | Trialant

S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas | NCT00217620 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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