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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054574
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : August 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: panitumumab Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (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
Actual Primary Completion Date : September 2003
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Panitumumab

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of prostate cancer with rising PSA values without metastasis

    • PSA must be at least 5 ng/mL
    • PSA must show an increase above a reference level on 2 separate occasions
  • Must have tumor over-expressing epidermal growth factor receptor (EGFr) by immunohistochemistry

    • Staining must be 2+ or 3+ in at least 10% of evaluated tumor cells
    • Must have tissue available for diagnostics
  • Must have failed prior front-line luteinizing hormone-releasing hormone (LHRH) analogue (e.g., leuprolide or goserelin) OR failed orchiectomy and have castrate levels of testosterone (less than 50 mg/mL) NOTE: Must continue on a LHRH analogue (unless an orchiectomy was performed) throughout the study



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN
  • AST and ALT no greater than 3 times ULN


  • Creatinine less then 2.2 mg/dL
  • Calcium no greater than ULN


  • Left ventricular ejection fraction at least 45% by MUGA
  • No myocardial infarction within the past year


  • HIV negative
  • Fertile patients must use effective contraception during and for 1 month after study
  • No other malignancy within the past 5 years except basal cell carcinoma
  • No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation, administration, or interpretation


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • At least 6 weeks since prior steroidal or nonsteroidal antiandrogens (4 weeks for flutamide)
  • Concurrent steroid therapy allowed as replacement therapy only


  • Not specified


  • See Disease Characteristics


  • At least 30 days since prior investigational therapy
  • At least 30 days since prior anticancer therapy
  • No prior systemic therapy for prostate cancer (except hormonal therapy)
  • No prior anti-EGFr therapy
  • Concurrent antihypercalcemic treatment allowed in the presence of elevated calcium levels but not as cancer therapy for bone disease
  • No other concurrent anti-EGFr therapy
  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054574

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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
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center

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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00054574     History of Changes
Other Study ID Numbers: CDR0000269889
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012
Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents