Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

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 disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1
• Life expectancy > 6 months
• ANC ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• AST and ALT < 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