NCT00061126

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 2004

First QC Date

May 21, 2003

Last Update Submit

June 23, 2005

Conditions

Prostate Cancer

Keywords

Prostate CancerPSAHormone refractoryRising PSA

Interventions

ABX-EGFDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

Stanford Medical Center

Stanford, California, 94303, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34652, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute, Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2003

First Posted

May 22, 2003

Study Start

April 1, 2003

Last Updated

June 24, 2005

Record last verified: 2004-09

Locations

US(9)