Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
Brief 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.
Detailed 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.
Interventions
BIOLOGICALpanitumumab
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed