Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: bevacizumab
Intervention description: 15 mg/kg over 90 minutes every 3 weeks
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: papillary renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of kidney cancer by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in
      treating patients with unresectable or metastatic kidney cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed papillary renal cell carcinoma (RCC)

               -  Unresectable and/or metastatic disease

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension and is ≥ 10 mm by spiral CT scan

          -  No known CNS (central nervous system) disease

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0-1

          -  Life expectancy > 6 months

          -  ANC (absolute neutrophil count) ≥ 1,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10.0 g/dL

          -  Total bilirubin ≤ 2.0 mg/dL

          -  AST (aspartate aminotransferase) and ALT (Alanine transaminase) < 3 times normal

          -  Creatinine clearance > 50 mg/mL

          -  Calcium < 12 mg/dL (when corrected for level of serum albumin)

          -  No known HIV infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  Inadequately controlled hypertension (defined as systolic blood pressure [BP] > 150 mm
             Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications)

          -  Prior history of hypertensive crisis or hypertensive encephalopathy

          -  New York Heart Association class II-IV congestive heart failure

          -  Myocardial infarction or unstable angina within the past 6 months

          -  Stroke or transient ischemic attack within the past 6 months

          -  Significant vascular disease (e.g., aortic aneurysm or aortic dissection)

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Significant traumatic injury within the past 28 days

          -  Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the
             past 6 months

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Proteinuria at screening as demonstrated by either of the following:

               -  Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening

               -  Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein > 1g

          -  Known hypersensitivity to any component of bevacizumab

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic treatment for metastatic papillary RCC

          -  At least 4 weeks since prior palliative radiotherapy of painful areas

          -  More than 28 days since prior major surgical procedure or open biopsy

          -  No concurrent major surgical procedure

          -  More than 7 days since prior core biopsy or other minor surgical procedure, excluding
             placement of a vascular access device

          -  Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at
             high-risk for arterial thromboembolic disease