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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
panitumumab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00054574
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
panitumumab

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Belldegrun, MD, FACS
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1738
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

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