Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: sorafenib tosylate
Intervention description: Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: clear cell renal cell carcinoma; recurrent renal cell cancer; stage IV renal cell cancer

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 how well sorafenib works in treating patients with
      metastatic kidney cancer that has not responded to sunitinib or bevacizumab.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed renal cell carcinoma with a component of clear cell histology

               -  Metastatic disease

          -  Disease progression, as defined by RECIST criteria, after prior treatment with
             sunitinib malate or bevacizumab

               -  Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses
                  of bevacizumab AND have RECIST-defined objective progression during or within 4
                  months after completing treatment with sunitinib malate or bevacizumab

          -  Measurable disease by RECIST criteria

          -  CNS metastases allowed provided patient has undergone prior surgery and/or
             radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI
             ≥ 2 weeks after treatment of CNS metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

          -  WBC ≥ 3,000/μL

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelet count ≥ 75,000/μL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST/ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 2.0 times ULN

          -  Negative pregnancy test

          -  No significant cardiovascular disease, including any of the following:

               -  Congestive heart failure (New York Heart Association class III-IV heart disease)

               -  Active angina pectoris requiring nitrate therapy

               -  Uncontrolled dysrhythmias

               -  Cardiovascular event within the past 6 months (e.g., transient ischemic
                  attack/cerebrovascular accident, myocardial infarction, or vascular surgery)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and
             recovered

          -  No prior sorafenib tosylate

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No concurrent prophylactic growth factors