Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring Recurrent clear cell renal cell carcinoma, Bevacizumab, Erlotinib, Imatinib
Eligibility Criteria
Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy Previous nephrectomy is required Maximum of 1 previous systemic regimen for metastatic disease. Able to perform activities of daily living with minimal assistance Measurable disease Adequate bone marrow, liver and kidney Written informed consent. Exclusion Criteria: Age < 18 years Treatment with more than 1 previous systemic regimen History of heart attack within 6 months Clinically significant cardiovascular disease Moderate to severe vascular disease. Active brain metastases. History or evidence by physical examination of brain tumor Seizures not controlled with standard medical therapy history of stroke or other serious disorders of the nervous system Clinical history of coughing or vomiting blood within the past 3 months. PEG tubes or G tubes Chronic therapy with NSAIDS or other platelet inhibitors Proteinuria Nonhealing wound, ulcer, or long bone fracture Clinical evidence or history of a bleeding disorder Requiring full dose anticoagulation with coumadin Receiving chronic steroid therapy Significant medical conditions. Tumors other than clear cell History of stroke within 6 months. History of abdominal fistula,perforation,or abscess within 6 months. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Intervention
In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily