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Investigator(s):
Olivier Rixe, M.D., Ph.D. Principal Investigator Phone: 301-435-2279 rixeo@mail.nih.gov
Referral Contact(s):
Maureen Edgerly, R.N., M.A. Research Nurse Phone: 301-435-5604 Fax: 301-402-1608 edgerlym@mail.nih.gov

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Primary Eligibility:

• Pathologically confirmed renal cell carcinoma
  • Metastatic or unresectable disease
  • Predominant clear cell histology (> 70%)
• Disease progression during or after completion of treatment with a VEGF-receptor tyrosine kinase inhibitor
• Primary tissue (as block or unstained slides) required
• Measurable disease
• No known CNS disease
  • Previously treated brain metastases allowed provided there is no ongoing requirement for steroids AND no evidence of progression or hemorrhage for ≥ 3 months after treatment
    • Stable dose of anticonvulsants allowed
    • Treatment for brain metastases may have included whole-brain radiotherapy, radiosurgery, or a combination
• No symptomatic spinal cord compression
• Recovered from all prior therapy (alopecia allowed)
• No prior cumulative radiotherapy to > 25% of the total bone marrow
• No prior bevacizumab or ixabepilone
• Prior aldesleukin, interferon, and/or mTOR treatment allowed
• No concurrent antiretroviral therapy for HIV-positive patients, concurrent radiotherapy, or concurrent CYP3A4 inhibitors
• ECOG 0–2
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 x upper limit of normal (ULN)
• Proteinuria ≤ 500 mg by 24-hour urine collection
• AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver function abnormalities are due to underlying malignancy)
• Total bilirubin ≤ 1.5 x ULN
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 6 months after the completion of bevacizumab therapy
• No other invasive malignancies within the past 2 years except non-melanoma skin cancer, non-invasive bladder cancer, stage I endometrial cancer, or cervical cancer
• No medical condition that would preclude study participation
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

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Treatment Plan:

• Patients receive bevacizumab IV over 30–90 minutes on Day 1 and ixabepilone IV over 1 hour on Days 1–5
• Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
• Patients undergo dynamic contrast-enhanced MRI at baseline, after every two courses, and after completion of treatment
• Patients undergo periodic biopsies and blood sample collection
• After completion of study treatment, patients are followed every 3 months

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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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 1/14/09