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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.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Abgenix
ClinicalTrials.gov Identifier:
NCT00061126
First received: May 21, 2003
Last updated: June 23, 2005
Last verified: September 2004
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
UCLA School of Medicine
Los Angeles, California, United States, 90095
Stanford Medical Center
Stanford, California, United States, 94303
United States, Florida
Advanced Research Institute
New Port Richey, Florida, United States, 34652
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Cancer Institute, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Abgenix
Immunex Corporation
  More Information

No publications provided

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

Keywords provided by Abgenix:
Prostate Cancer
PSA
Hormone refractory
Rising PSA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014