Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
Condition: Adult Angiosarcoma; Adult Epithelioid Sarcoma; Adult Leiomyosarcoma; Adult Malignant Fibrous Histiocytoma; Adult Neurofibrosarcoma; Adult Synovial Sarcoma; Ovarian Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Uterine Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage III Uterine Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Stage IV Uterine Sarcoma; Uterine Carcinosarcoma; Uterine Leiomyosarcoma
MeSH terms: Sarcoma; Leiomyosarcoma; Sarcoma, Synovial; Carcinosarcoma; Hemangiosarcoma; Histiocytoma; Histiocytoma, Benign Fibrous; Histiocytoma, Malignant Fibrous; Neurofibrosarcoma; Recurrence
Intervention: sorafenib tosylate
Intervention description: Given orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sorafenib works in treating patients with
      metastatic, locally advanced, or recurrent sarcoma. 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed sarcoma, including any of the following
             neoplastic subtypes:

               -  Giant hemangioma

               -  Angiosarcoma (including epithelioid hemangioendothelioma)

               -  Malignant peripheral nerve sheath tumor

               -  Leiomyosarcoma (closed to accrual as of 11/29/06)

               -  High-grade undifferentiated pleomorphic sarcoma (i.e., malignant fibrous
                  histiocytoma [including myxofibrosarcoma]) (closed to accrual as of 11/29/06)

               -  Synovial sarcoma (closed to accrual as of 11/29/06)

               -  Carcinosarcoma (closed to accrual as of 11/29/06)

          -  Metastatic, locally advanced, or locally recurrent disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

               -  Lesions in a previously irradiated area may be considered measurable provided
                  there is evidence of subsequent disease progression that cannot be attributed to
                  necrosis or bleeding

          -  No gastrointestinal stromal tumor

          -  No known brain metastases

          -  Performance status - ECOG 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  No evidence of bleeding diathesis

          -  Bilirubin ≤ 1.5 mg/dL

          -  INR ≤ 1.5

          -  AST and ALT ≤ 2.5 times upper limit of normal

          -  Creatinine ≤ 1.5 mg/dL

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No uncontrolled hypertension

          -  No history of allergic reaction to compounds of similar chemical or biologic
             composition to sorafenib

          -  No known HIV positivity

          -  No active or ongoing infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No swallowing dysfunction that would preclude the swallowing of tablets

          -  Other malignancies allowed provided sarcoma is the primary disease requiring treatment

          -  No other uncontrolled illness

          -  No more than 1 prior chemotherapy regimen for recurrent or metastatic disease (≤ 3
             regimens for angiosarcoma or malignant peripheral nerve sheath tumor)

               -  Adjuvant chemotherapy completed > 1 year prior to study entry is not considered a
                  line of prior treatment

          -  More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  At least 3 weeks since prior radiotherapy

          -  Recovered from prior antitumor therapy

               -  Alopecia allowed

          -  No prior sorafenib

          -  No prior small molecule inhibitors of MAPK signaling intermediates

          -  No concurrent therapeutic anticoagulation

               -  Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial
                  devices allowed provided requirements for PT, INR, or PTT requirements are met

          -  No other concurrent investigational agents

          -  No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
             carbamazepine, or phenobarbital)

          -  No concurrent rifampin or Hypericum perforatum (St. John's wort)