A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma

Inclusion 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 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