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OpenTrials
Completed

NCT Number: NCT00061126

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABX-EGF

Drug

Sponsors and collaborators

Lead sponsor

Abgenix

Industry

Collaborators

  • Immunex Corporation

Registry information

Official study title

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

Important dates

Study start
2003
First posted
May 22, 2003
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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