Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion and exclusion 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 contacts and locations
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Data sourced from clinicaltrials.gov
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