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.
- To evaluate the progression-free survival when bevacizumab is administered to patients
with unresectable and/or metastatic papillary renal cell carcinoma.
- To further evaluate the safety of bevacizumab in these patients.
- To examine, in a preliminary manner, the response rate to bevacizumab in these
- To collect and store blood and urine samples for future analysis.
- To evaluate overall survival when bevacizumab is administered to these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.
- 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
- 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
- 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