Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054574
• Other study ID #: CDR0000269889
• Secondary ID: UCLA-0206074ABX-
• Status: Completed
• Phase: Phase 2
• Start date: November 2002
• Est. completion date: February 2004

Study information

• Verified date: August 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• panitumumab

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States,