Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer
Condition: Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: therapeutic conventional surgery; sorafenib tosylate; laboratory biomarker analysis
Intervention description: Undergo cytoreductive nephrectomy; Given orally; 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: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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. Giving sorafenib before and after surgery may
      be an effective treatment for kidney cancer. This phase II trial is studying how well
      sorafenib works in treating patients who are undergoing surgery for metastatic kidney cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed metastatic clear cell RCC who
             are eligible for cytoreductive nephrectomy as agreed upon by Medical Oncology and
             Urology team members; patients with metastatic disease eligible for cytoreductive
             nephrectomy should have the following characteristics: resectable primary tumor (no
             gross adjacent organ invasion, no or minimal abdominal lymphadenopathy, no or minimal
             inferior vena caval involvement), bulk of metastatic disease within the primary tumor,
             absence of multiple liver metastases, no more than 2 organ sites involved with
             metastases

          -  Patients must have measurable disease, defined as a lesion that can be accurately
             measured in at least one dimension (longest diameter to be recorded) and measures >=
             20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT)
             scan

          -  ECOG performance status =< 1

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Hgb > 9.0 g/dL

          -  Total bilirubin =< 2.0 mg/dl

          -  Albumin > 3.0 g/dL

          -  Serum creatinine =< 2.0 mg/dl

          -  AST (SGOT) and/or ALT (SGPT) =< 2.5 x institutional upper limit of normal for subjects
             without evidence of liver metastases

          -  AST (SGOT) and/or ALT (SGPT) =< 5 X institutional upper limit of normal for subjects
             with documented liver metastases

          -  Female patients of childbearing potential must have a normal plasma beta human
             chorionic gonadotropin (beta-HCG) within 24 hours prior to enrolling in the study due
             to the possible teratogenic effect; however, patients will be eligible if their
             beta-HCG is elevated and is determined to be due to malignancy

          -  Patients of child fathering or childbearing potential must agree to practice a form of
             medically acceptable birth control while on study

          -  Patients must give written informed consent prior to initiation of therapy, in keeping
             with the policies of the institution; patients with a history of major psychiatric
             illness must be judged able to fully understand the investigational nature of the
             study and the risks associated with the therapy

          -  Patients must have ability to comply with study and/or follow-up procedures

          -  Prior biopsy material (blocks or unstained slides) must be available for comparison
             purposes

        Exclusion Criteria:

          -  No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma
             of any site, or other cancers for which the patient has been adequately treated and
             disease free for 5 years

          -  Patients must not have received any systemic anticancer therapy or radiotherapy within
             4 weeks prior to entering the study or those who have not recovered from adverse
             events due to agents administered more than 4 weeks earlier

          -  Patients must not be scheduled to receive another experimental drug while on this
             study; patients are permitted to be on concomitant bisphosphonates

          -  Patients who are incapable of swallowing pills are excluded from this study

          -  Patients must not have a primary brain tumor, any brain metastases, leptomeningeal
             disease, seizure disorders not controlled with standard medical therapy, or history of
             stroke

          -  Patients must not have active acute infections that could be worsened by anticancer
             therapy or interfere with this study

          -  Patients must not have clinically significant cardiovascular disease, recent
             myocardial infarction (i.e. last 6 months), (unstable angina), New York Heart
             Association (NYHA) grade II or greater congestive heart failure, serious cardiac
             dysrhythmia requiring medication, or peripheral vascular disease (grade II or greater)

          -  Patients must not have history of other diseases, metabolic dysfunction, physical
             examination finding, or clinical laboratory finding giving reasonable suspicion of a
             disease or condition that contraindicates the use of an investigational drug or that
             might affect the interpretation of the results of the study or render the subject at
             high risk from treatment complications

          -  Patients with uncontrolled hypertension > 140/90 are excluded from the study

          -  Patients must not have any history of bleeding diathesis; patients must not be on
             therapeutic anticoagulation; prophylactic anticoagulation (i.e. low dose coumadin) of
             venous or arterial access devices is allowed provided that the requirements for PT,
             INR or PTT are met

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with BAY 43-9006

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study