Sorafenib in Treating Patients With Advanced Malignant Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Intervention: Sorafenib
Intervention description: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific

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 the side effects and best dose of sorafenib and to
      see how well it works in treating patients with advanced malignant solid tumors.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically or cytologically confirmed metastatic or unresectable solid tumor for
             which standard curative or palliative measures do not exist or are no longer effective
             or solid tumor for which sorafenib is considered acceptable therapy

          -  Age > 18 years old

          -  Performance Status 0 - 2

          -  Measurable or non-measurable disease.

          -  Adequate bone marrow, liver and renal function

          -  Any number of prior chemotherapy regimens are allowed.

          -  Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at
             least 2 weeks prior to start of this protocol and all side effects resolved to grade 1
             or less. Any prior radiation must have been completed at least 2 weeks prior to start
             of therapy.

          -  Women of childbearing potential must have a negative pregnancy test performed within 7
             days prior to the start of treatment

          -  Women of childbearing potential and men must agree to use adequate contraception prior
             to study entry and for the duration of study participation. Men should use adequate
             birth control for at least three months after the last administration of sorafenib.

          -  Ability to understand and the willingness to sign a written informed consent.

          -  International normalized ratio < 1.5 or a Prothrombin Time/Partial thromboplastin time
             within normal limits.

        Exclusion Criteria

          -  Prior therapy with sorafenib or sunitinib.

          -  Cardiac disease: Congestive heart failure > class II New York Heart Association.

          -  Symptomatic or uncontrolled brain metastasis.

          -  No component of squamous carcinoma can be present in any patient with non-small cell
             lung cancer

          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

          -  Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
             pressure > 90 mmHg, despite optimal medical management.

          -  Known HIV infection or chronic Hepatitis B or C.

          -  Active clinically serious infection > CTCAE Grade 2.

          -  Thrombolic or embolic events such as a cerebrovascular accident including transient
             ischemic attacks within the past 6 months.

          -  Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of
             study drug.

          -  Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
             study drug.

          -  Serious non-healing wound, ulcer, or bone fracture.

          -  Evidence or history of bleeding diathesis or coagulopathy

          -  Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
             dose of study drug.

          -  Use of St. John's Wort or rifampin

          -  Known or suspected allergy to sorafenib or any agent given in the course of this
             trial.

          -  Any condition that impairs patient's ability to swallow whole pills.

          -  Any significant malabsorption problem.

          -  Therapy with bevacizumab < 3 months prior to first dose of study drug.