monoclonal antibody therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

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.

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

Keywords: recurrent prostate cancer stage i prostate cancer stage ii prostate cancer stage iii prostate cancer