Kidney Cancer Clinical Trial

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

Summary

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).

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Full Description

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

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Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00193154

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There are 2 Locations for this study

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Medical Oncology LLC
Baton Rouge Louisiana, 70809, United States
Grand Rapids Oncology Program
Grand Rapids Michigan, 49503, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT00193154

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

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