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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014