ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body

This study has been completed.

First Received: May 21, 2003 Last Updated: June 23, 2005 History of Changes

Sponsor:	Abgenix
Collaborator:	Immunex Corporation
Information provided by:	Abgenix
ClinicalTrials.gov Identifier:	NCT00061126

Purpose

A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body.

Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.

Condition	Intervention	Phase
Prostate Cancer	Drug: ABX-EGF	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients With Hormone Resistant Prostate Cancer With or Without Metastasis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Panitumumab

U.S. FDA Resources

Further study details as provided by Abgenix:

Estimated Enrollment:	50
Study Start Date:	April 2003

Eligibility

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

Criteria

Inclusion Criteria:

Male 18 years of age or older
Has tumor tissue available for diagnostics
Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study
ECOG score of 0 or 1

Exclusion Criteria:

Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent)
Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed)
Known to be HIV positive
Myocardial infarction within one year prior to entering the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061126

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Stanford Medical Center
Stanford, California, United States, 94303
UCLA School of Medicine
Los Angeles, California, United States, 90095
United States, Florida
Advanced Research Institute
New Port Richey, Florida, United States, 34652
United States, Pennsylvania
University of Pittsburgh Cancer Institute, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
University of Washington
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Abgenix

Immunex Corporation

More Information

No publications provided

Study ID Numbers:	ABX-0310, ABX-EGF
Study First Received:	May 21, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00061126 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abgenix:

Prostate Cancer
PSA
Hormone refractory
Rising PSA

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010