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

Sponsor

Abgenix (Industry)

Overall Status

Completed

CT.gov ID

NCT00061126

Collaborator

Immunex Corporation (Industry)

Enrollment

Locations

5.6

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: ABX-EGF	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	UCLA School of Medicine	Los Angeles	California	United States	90095
3	Stanford Medical Center	Stanford	California	United States	94303
4	Advanced Research Institute	New Port Richey	Florida	United States	34652
5	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
6	University of Pittsburgh Cancer Institute, Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
7	Urology San Antonio Research	San Antonio	Texas	United States	78229
8	University of Washington	Seattle	Washington	United States	98109
9	Madigan Army Medical Center	Tacoma	Washington	United States	98431