Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have prostate cancer that has not responded to hormone therapy.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis|
|Study Start Date:||November 2002|
|Study Completion Date:||February 2004|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
- 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 without metastasis.
- 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 toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1738|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Arie Belldegrun, MD, FACS||Jonsson Comprehensive Cancer Center|