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

Study Overview
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Brief Summary
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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).

Detailed Description
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Upon determination of eligibility, all patients will receive: Tarceva + Avastin

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: OSI-774
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSI-774 & bevacizumab<br>OSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days. | Drug: OSI-774<br>* 150mg PO, days 1-28, cycle repeated every 28 days<br>* Other names: Tarceva;Drug: Bevacizumab<br>* 10mg/kg, IV infusion, Days 1 and 15, 28 day cycles<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the combination of Tarceva and Avastin |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 18 months | 
| Progression-free survival |  | 18 months | 
| Overall Survival |  | 18 months | 
| Overall tolerability and toxicity of this combination regimen |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Cancer