Clinical Trial: ABX-EGF (a monoclonal antibody) Given to Patients with Prostate Cancer with or without Tumor in Other Parts of the Body


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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.

Sponsored by:	Abgenix Immunex Corporation
Information provided by:	Abgenix

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	Treatment or Intervention	Phase
Prostate Cancer	Drug: ABX-EGF	Phase II

MedlinePlus related topics: Prostate Cancer

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:

Expected Total Enrollment: 50

Study start: April 2003

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male

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

Location Information

Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

California
Stanford Medical Center, Stanford, California, 94303, United States

UCLA School of Medicine, Los Angeles, California, 90095, United States

Florida
Advanced Research Institute, New Port Richey, Florida, 34652, United States

Pennsylvania
University of Pittsburgh Cancer Institute, Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States

Texas
Urology San Antonio Research, San Antonio, Texas, 78229, United States

Washington
Madigan Army Medical Center, Tacoma, Washington, 98431, United States

University of Washington, Seattle, Washington, 98109, United States

More Information

Study ID Numbers: ABX-0310; ABX-EGF
Record last reviewed: September 2004
Record first received: May 21, 2003
ClinicalTrials.gov Identifier: NCT00061126
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20

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