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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2014-03-31

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).

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Detailed Description

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Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Conditions

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Kidney Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OSI-774 & bevacizumab

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.

Group Type EXPERIMENTAL

OSI-774

Intervention Type DRUG

150mg PO, days 1-28, cycle repeated every 28 days

Bevacizumab

Intervention Type DRUG

10mg/kg, IV infusion, Days 1 and 15, 28 day cycles

Interventions

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OSI-774

150mg PO, days 1-28, cycle repeated every 28 days

Intervention Type DRUG

Bevacizumab

10mg/kg, IV infusion, Days 1 and 15, 28 day cycles

Intervention Type DRUG

Other Intervention Names

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Tarceva Avastin

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No