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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054574 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: panitumumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer with rising PSA values without metastasis
Must have tumor over-expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study ID Numbers: | CDR0000269889, UCLA-0206074, ABX-0301 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00054574 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Antibodies, Monoclonal Antibodies Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Recurrence Immunoglobulins |
Neoplasms Neoplasms by Site |