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Investigator(s):
Ramaprasad Srinivasan, M.D., Ph.D. Principal Investigator Phone: 301-496-6353 ramasrin@mail.nih.gov
Referral Contact(s):
Geri Hawks, R.N., B.S.N. Research Nurse Phone: 301-402-7913 Fax: 301-435-9262 ghawks@mail.nih.gov

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Key Eligibility Criteria:

• Diagnosis of advanced renal cell cancer (RCC) associated with hereditary leiomyomatosis and renal cell cancer (HLRCC) or sporadic papillary RCC
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
• ≤ two prior regimens targeting the vascular endothelial growth factor (VEGF) pathway
• No prior bevacizumab therapy
• ≥ 18 years of age
• ECOG 0–2
• WBC count ≥ 3,000/μL, absolute neutrophil count ≥ 1,500/μL, platelet count ≥ 100,000/μL
• Serum creatinine ≤ 2 x upper limit of reference range or creatinine clearance ≥ 30 mL/min
• AST and ALT < 2.5 x upper limit of reference range, total bilirubin < 1.5 x upper limit of reference range (< 3 x upper limit of reference range in patients with Gilbert’s disease), alkaline phosphatase ≤ 2.5 x upper limit of reference range (or ≤ 5 x upper limit of reference range if considered to be related to liver or bone metastases by the principal investigator)
• No history of major bleeding, recent or active myocardial ischemia, GI perforation, cerebrovascular accidents or other significant intercurrent illness
• No coagulopathy or bleeding diathesis
• No recent surgery (< 4 weeks) or inadequately healed surgical scars
• No known brain metastases unless treated with an appropriate modality with no evidence of progression/recurrence for > 3 months
• Not pregnant or breastfeeding

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Study Outline:

• Bevacizumab by IV (intravenous infusion) through a vein every 2 weeks
• Erlotinib each day by mouth
• Dose reductions and drug interruptions for unacceptable toxicity will be allowed
• Disease response evaluations every 8 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 6/21/10