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

Sponsors and Collaborators:	Sarah Cannon Research Institute AstraZeneca Genentech
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193154

Purpose

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).

Condition	Intervention	Phase
Kidney Cancer	Drug: OSI-774 Drug: Bevacizumab	Phase II

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Efficacy of the combination of Tarceva and Avastin

Secondary Outcome Measures:

Objective response rate
Progression-free survival
Overall Survival
Overall tolerability and toxicity of this combination regimen

Estimated Enrollment:	60
Study Start Date:	February 2003

Detailed Description:

Upon determination of eligibility, all patients will be receive:

Tarceva + Avastin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193154

Sponsors and Collaborators

Sarah Cannon Research Institute

AstraZeneca

Genentech

Investigators

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

More Information

Publications of Results:

Hainsworth JD, Sosman JA, Spigel DR, Edwards DL, Baughman C, Greco A. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol. 2005 Nov 1;23(31):7889-96. Epub 2005 Oct 3.

Study ID Numbers:	SCRI GU 17, AVF2488s
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193154
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sarah Cannon Research Institute:

Kidney Cancer

Study placed in the following topic categories:

Erlotinib
Urogenital Neoplasms
Renal cancer
Bevacizumab
Urologic Neoplasms
Kidney cancer
Carcinoma

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors

Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009