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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

ABX-0310

NCT ID:

NCT00061126

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • PSA
  • Hormone refractory
  • Rising PSA
  • Prostatic Neoplasms

Name

Location

UCLA School of MedicineLos Angeles, California  900121973
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Madigan Army Medical CenterTacoma, Washington  98431-5048
Urology San Antonio ResearchSan Antonio, Texas  78229
University of WashingtonSeattle, Washington  98195
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Advanced Research InstituteNew Port Richey, Florida  34652
Stanford Medical CenterStanford, California  94303
University of Pittsburgh Cancer Institute, Hillman Cancer CenterPittsburgh, Pennsylvania  15232