Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

Arie Belldegrun

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00054574
Information obtained from ClinicalTrials.gov on December 14, 2011

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