A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
- Determine the clinical effect of monoclonal antibody ABX-EGF, determined by the PSA
response, in patients with hormone-resistant prostate cancer with rising PSA values
- Determine the pharmacokinetics and safety profile (including immunogenicity) of this
drug in these patients.
- Determine the overall survival of patients treated with this drug.
- Determine the time to disease progression and time to PSA progression in patients
treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly. Treatment continues
every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Arie Belldegrun, MD, FACS
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|