Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07)
Condition: Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Osteosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Osteosarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
MeSH terms: Sarcoma; Osteosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Recurrence
Intervention: sorafenib tosylate; therapeutic conventional surgery; laboratory biomarker analysis; pharmacological study; computed tomography; dynamic contrast-enhanced magnetic resonance imaging
Intervention description: Given PO; Undergo surgery; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sorafenib works in treating patients with soft
      tissue sarcoma. Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow
      to the tumor and blocking some of the enzymes needed for tumor cell growth
    

Eligibility criteria:

        Inclusion Criteria:

          -  There are two groups of patients eligible for this study; treatment group 1 consists
             of patients with extremity sarcomas other than potentially curable osteosarcoma or
             Ewing's sarcoma who are candidates for potentially curative surgery; treatment group 2
             consists of patients with metastatic or inoperable sarcoma, for which there is no
             known curative or survival prolonging palliative therapy, or failure of these
             therapies; patients must have at least one site of measurable disease by radiologic
             imaging techniques; patients must have at least one palpable tumor mass with no
             overlying viscera which is amenable to biopsy; the tumor mass should be approximately
             2 cm or greater in diameter; patients with smaller palpable tumors are eligible if
             participation is approved by the treating surgeon after discussion with the study
             chairperson

               -  As of 5/30/07, no subjects will accrue to Treatment Group I

          -  Life expectancy >= 2 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Pretreatment laboratory data, obtained within 14 days of study entry, must meet the
             following criteria:

          -  Absolute Neutrophil Count (ANC) >= 1,500/mm^3

          -  Platelets >= 100,000/mm^3

          -  Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5-times the upper limit of normal
             (ULN)

          -  Serum glutamic-pyruvic transaminase (SGPT)=< 2.5-times ULN

          -  Total Bilirubin =< ULN

          -  Serum creatinine =< 1.5-times ULN

          -  >= 3 weeks since major surgery unrelated to study disease (sarcoma)

          -  >= 3 weeks since chemotherapy or radiation therapy (6 weeks for nitrosourea or
             mitomycin C chemotherapy)

          -  No prior treatment with sorafenib (BAY 43-9006) or specific inhibitors of
             mitogen-activated protein kinase (MAPK) pathways are permitted; a previously
             irradiated tumor site cannot be used for clinical or correlative measurements,
             although irradiation to sites other than a measurable site is permitted; there are no
             limitations on the extent or type of prior therapy received by the patient other than
             the time intervals indicated in the above and demonstrating complete recovery from any
             adverse effects associated by satisfying all relevant eligibility criteria

          -  Patients who are on warfarin anticoagulation are allowed to participate as long as
             they are converted to a low molecular weight heparin (e.g. lovenox) from study entry
             until at least day 56

          -  Women of childbearing potential must not be pregnant or lactating; all women of
             childbearing potential (age < 50, last menstrual period [LMP] < 12 months ago) must
             have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L of
             beta-HCG) within 72 hr prior to receiving the study medication; BAY43-9006 has
             antiproliferative effects, which may be harmful to the developing fetus or nursing
             infant

          -  Fertile males and females must use adequate contraception

          -  Signed informed consent

        Exclusion Criteria:

          -  Ewing's sarcoma or osteosarcoma that is potentially curable with surgery,
             chemotherapy, and/or radiation therapy

          -  Active brain metastases including evidence of cerebral edema by CT scan or MRI, or
             progression from prior imaging study, any requirements for steroids, or
             enzyme-inducing anti-convulsant agents, or clinical symptoms of/from brain metastases;
             patients with treated and/or stable brain metastasis who are asymptomatic can be
             enrolled, if otherwise eligible

          -  Any uncontrolled serious medical or psychiatric illness; particular note is given to
             uncontrolled hypertension (discretion left to investigators) and significant
             proteinuria > 1 gm/24 hr (does not require quantitation in absence of clinical
             indication)

          -  Patients receiving other investigational agents

          -  Human immunodeficiency virus (HIV) patients receiving combination anti-retroviral
             therapy are excluded because of potential pharmacokinetic interactions