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

Abgenix

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: ABX-EGF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00061126

ABX-EGF

ABX-0310

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No 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