Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Condition: Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sorafenib Tosylate; Recombinant Interferon Alfa-2b; Laboratory Biomarker Analysis
Intervention description: Given orally 400 mg orally (PO) every 12 hours; Given subcutaneously (SC) 0.5 million with +/- 5 % variance (0.475 MU - 0.525 MU); Dose level 0: 0.5 X 10^6 international units twice daily; Correlative studies
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well
      they work compared to sorafenib alone in treating patients with metastatic kidney cancer.
      Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and
      interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with
      interferon alfa-2b may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed metastatic clear cell RCC

          -  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 CT scan

          -  ECOG performance status =< 1

          -  Absolute neutrophil count >= 1,500/μL

          -  Platelets >= 100,000/μL

          -  Hgb > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to maintain
             or exceed this level)

          -  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 (βHCG) within 24 hours prior to enrolling in the study due to
             the possible teratogenic effect; however, patients will be eligible if their βHCG
             elevation is consistent with malignancy rather than pregnancy

          -  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; the only approved consent is attached
             to this protocol

          -  Patients must have ability to comply with study and/or follow-up procedures

          -  Patients must be able to swallow pills

        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 for renal cell
             carcinoma; patients must not have received any radiotherapy for renal cell carcinoma
             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 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, myocardial
             infarction within the past year (unstable angina), New York Heart Association (NYHA)
             Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory
             to medical management, or peripheral vascular disease (Grade II or greater)

          -  Patients must not have uncontrolled hypertension

          -  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

          -  Pregnant women are excluded from this study because BAY 43-9006 is a kinase inhibitor
             agent with the potential for teratogenic or abortifacient effects; because there is an
             unknown but potential risk for adverse events in nursing infants secondary to
             treatment of the mother with BAY 43-9006, breastfeeding should be discontinued if the
             mother is treated with BAY 43-9006

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with BAY 43-9006; appropriate studies will be undertaken
             in patients receiving combination anti-retroviral therapy when indicated

          -  Patients must not have a clinical history of coagulopathy, bleeding diathesis or
             thrombosis; patients must not be on therapeutic anticoagulation; prophylactic
             anticoagulation (ie low dose warfarin) of venous access devices is allowed provided
             that INR >= 1.5 is due to warfarin therapy; other patients with an INR >= 1.5 are
             excluded

          -  Patients must not have a history of severe depression

          -  Concomitant treatment with rifampin, St. John's wort, and the cytochrome p450
             enzyme-inducin antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital)