Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0206074 ABX-0301, NCT00054574

Objectives

1. 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.
2. Determine the pharmacokinetics and safety profile (including immunogenicity) of this drug in these patients.
3. Determine the overall survival of patients treated with this drug.
4. Determine the time to disease progression and time to PSA progression in patients treated with this drug.

Entry 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]

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 30-50 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Arie Belldegrun, MD, FACS, Principal investigator		Ph: 310-794-6584; 888-798-0719 Email: abelldegrun@mednet.ucla.edu

Registry Information
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
Trial Start Date		2002-11-14
Registered in ClinicalTrials.gov		NCT00054574
Date Submitted to PDQ		2002-12-17
Information Last Verified		2004-07-26
NCI Grant/Contract Number		P30-CA16042

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