Bortezomib and Bevacizumab ("BB-mib-mab") in Patients With Advanced or Recurrent Renal Cell Cancer (RCC)

Inclusion Criteria

• •Distant metastatic (TX NX M1) or locally recurrent renal cell carcinoma not amenable to cure by surgical or other means
• •Measurable or non-measurable (evaluable) disease either on imaging scan or physical examination
• •Pathological confirmation of the diagnosis of renal cell carcinoma either during prior nephrectomy or by biopsy of a primary or metastatic lesion - provision of a paraffin-embedded tissue block to confirm the diagnosis and allow molecular correlate assessment is required.
• •ECOG performance status 0 or 1.
• •Patients must have an AGC of greater than or equal to 1,500/mm3 and a platelet count of greater than or equal to 100,000/mm3. These tests must be obtained within 28 days of registration.
• •Patients must have a calculated or measured creatinine clearance greater than or equal to 40 ml/min obtained within 28 days prior to registration.
• •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
• •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• •Male subject agrees to use an acceptable method of contraception for the duration of the study.
• •May have been treated with interleukin and/or interferon but must not have had more than one line of prior cytotoxic chemotherapy
• •May have had up to one biologic therapy provided they have not had bortezomib or bevacizumab
• •May have had up to 2 prior vaccine therapies
• •May have been treated with radiation therapy, provided there are measurable or evaluable lesions outside the field of radiation
• •May have had radiation provided the patient has recovered from the side effects of the therapy (typically 2 weeks after final fraction) and less than 30% of the total bone marrow has been irradiated