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

NCT ID: NCT00061126

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer PSA Hormone refractory Rising PSA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ABX-EGF

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Immunex Corporation

INDUSTRY

Sponsor Role collaborator

Abgenix

INDUSTRY

Sponsor Role lead

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

Stanford Medical Center

Stanford, California, United States

Site Status

Advanced Research Institute

New Port Richey, Florida, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute, Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Urology San Antonio Research

San Antonio, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ABX-EGF

Identifier Type: -

Identifier Source: secondary_id

ABX-0310

Identifier Type: -

Identifier Source: org_study_id