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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: Bevacizumab

Drug: OSI-774

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193154

SCRI GU 17

AVF2488s

Details and patient eligibility

About

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).

Full description

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.