Spots Global Cancer Trial Database for Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

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Trial Identification

Brief Title: Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

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 ID: NCT00054574

Conditions

Prostate Cancer

Interventions

panitumumab

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.