NCT00054574

Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	panitumumab

Timeline

• Start date: 2002-11-01
• Primary completion: 2003-09-01
• Completion: 2004-02-01
• First posted: 2003-02-06
• Last updated: 2020-08-03

Locations

2 sites across 1 country: United States