Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: panitumumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: panitumumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer