Status:
COMPLETED
OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
AstraZeneca
Genentech, Inc.
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 trial...
Detailed Description
Upon determination of eligibility, all patients will receive: Tarceva + Avastin
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00193154
Start Date
February 1 2003
End Date
March 1 2014
Last Update
April 1 2014
Active Locations (2)
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1
Medical Oncology LLC
Baton Rouge, Louisiana, United States, 70809
2
Grand Rapids Oncology Program
Grand Rapids, Michigan, United States, 49503