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

Prostate Cancer Clinical Trial

Official title:

A Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients With Hormone Resistant Prostate Cancer With or Without Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061126
• Other study ID #: ABX-0310
• Secondary ID: ABX-EGF
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2003
• Last updated: June 23, 2005
• Start date: April 2003

Study information

• Verified date: September 2004
• Source: Abgenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ABX-EGF

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UCLA School of Medicine	Los Angeles	California
United States	Advanced Research Institute	New Port Richey	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute, Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Urology San Antonio Research	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Stanford Medical Center	Stanford	California
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Abgenix	Immunex Corporation

Country where clinical trial is conducted

United States,