Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00054574
First received: February 5, 2003
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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
Biological: panitumumab
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Study Start Date: November 2002
Study Completion Date: February 2004
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • 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

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054574

Locations
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
Investigators
Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00054574     History of Changes
Other Study ID Numbers: CDR0000269889, P30CA016042, UCLA-0206074, ABX-0301
Study First Received: February 5, 2003
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013