S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: sorafenib
Intervention description: 800 mg per day, daily until progression
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult angiosarcoma; adult leiomyosarcoma; adult liposarcoma; adult malignant hemangiopericytoma; recurrent adult soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma

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.
    

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