OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma

A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma

In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Metastatic or unresectable clear cell kidney cancer confirmed by biopsy
• Previous nephrectomy
• Maximum of 1 previous regimen for metastatic disease
• Ability to perform activities of daily living with minimal assistance
• Measurable disease
• Adequate bone marrow, liver and kidney function
• Give written informed consent prior to study entry

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Age < 18 years
• Treatment with more than one previous regimen for metastatic disease
• Clinically significant cardiovascular disease
• Active brain metastases
• History of CNS disease
• Clinical history of coughing or vomiting blood.
• History of thromboembolic disease.
• PEG or G-tube are ineligible.
• Current use of full dose anticoagulants or thrombolytic agents
• Chronic daily treatment with aspirin or NSAIDS
• Any clinical evidence or history of a bleeding or clotting disorder

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.