CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer

Inclusion Criteria: Histologically confirmed metastatic or unresectable renal cell cancer Must have a component of conventional clear cell histology The following histologies are excluded: True papillary Sarcomatoid features without any clear cell component Chromophobe Oncocytoma Collecting duct tumors Transitional cell carcinoma Measurable disease, defined as ≥ 1 lesion ≥ 2.0 cm in the longest diameter by conventional techniques OR ≥ 1.0 cm by spiral CT scan Tumor tissue (from primary tumor or metastases) available AND patient is willing to donate blood for research studies (phase II only) No CNS metastases by head CT scan or MRI Performance status - ECOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL No evidence of bleeding diathesis or coagulopathy No history of clinically significant bleeding or active bleeding Bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present) AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present) PT/INR ≤ 1.5 Patients on full-dose warfarin or stable-dose low molecular weight heparin must have INR > 1.5 but ≤ 3 Creatinine ≤ 1.5 times ULN Urine protein ≤ 1+ by dipstick or urinalysis Urine protein < 1,000 mg on a 24-hour urine collection No cerebrovascular accident within the past 6 months No peripheral vascular disease with claudication on < 1 block No New York Heart Association class II-IV congestive heart failure No angina pectoris requiring nitrate therapy No myocardial infarction within the past 6 months No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg despite medication No cardiac arrhythmias No other significant cardiovascular disease No ongoing hemoptysis Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3-4 months after study participation Fasting cholesterol ≤ 350 mg/dL Triglycerides ≤ 1.5 times ULN (may achieve using lipid lowering agents) No known hypersensitivity to recombinant human antibodies No significant traumatic injury within the past 4 weeks No serious or non-healing wound, ulcer, or bone fracture No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks No pathological conditions that confer a high risk of bleeding (e.g., tumor involving major vessels or known varices) No diabetes No other currently active malignancy except nonmelanoma skin cancer Patients are not considered to have a currently active malignancy if they have completed anticancer therapy AND are considered to be at < 30% risk of relapse No other uncontrolled serious medical or psychiatric condition At least 4 weeks since prior biologic response modifiers for metastatic disease No prior bevacizumab or mTOR inhibitors At least 4 weeks since prior chemotherapy for metastatic disease Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable and/or evaluable lesion that has not been irradiated At least 4 weeks since prior and no concurrent radiotherapy Prior nephrectomy allowed More than 4 weeks since prior major surgery or open biopsy More than 1 week since prior core biopsy No concurrent major surgery At least 4 weeks (2 weeks for vascular endothelial growth factor [VEGF] receptor tyrosine kinase inhibitor [RTKI] therapy) since prior and no more than 2 therapies (phase II) One of these therapies must have included a RTKI agent administered for a minimum of 4 weeks Concurrent full-dose warfarin or low molecular weight heparin allowed provided dose is stable AND INR requirements are met Concurrent zoledronate for bone metastases and/or hypercalcemia allowed provided therapy was initiated prior to study entry