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

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.

Sponsors and Collaborators:	Abgenix 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

MedlinePlus related topics:

Cancer Prostate Cancer

Drug Information available for:

Panitumumab

U.S. FDA Resources

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

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

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

Keywords provided by Abgenix:

Prostate Cancer

PSA

Hormone refractory

Rising PSA

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Prostatic Diseases

Genital Neoplasms, Male

Neoplasm Metastasis

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008