Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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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.
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Determine the pharmacokinetics and safety profile (including immunogenicity) of this drug in these patients.
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Determine the overall survival of patients treated with this drug.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of prostate cancer with rising PSA values without metastasis
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PSA must be at least 5 ng/mL
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PSA must show an increase above a reference level on 2 separate occasions
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Must have tumor over-expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
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Staining must be 2+ or 3+ in at least 10% of evaluated tumor cells
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Must have tissue available for diagnostics
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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
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Absolute neutrophil count greater than 1,500/mm^3
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Platelet count at least 100,000/mm^3
Hepatic
-
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
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Alkaline phosphatase no greater than 3 times ULN
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AST and ALT no greater than 3 times ULN
Renal
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Creatinine less then 2.2 mg/dL
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Calcium no greater than ULN
Cardiovascular
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Left ventricular ejection fraction at least 45% by MUGA
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No myocardial infarction within the past year
Other
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HIV negative
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Fertile patients must use effective contraception during and for 1 month after study
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No other malignancy within the past 5 years except basal cell carcinoma
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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
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At least 6 weeks since prior steroidal or nonsteroidal antiandrogens (4 weeks for flutamide)
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Concurrent steroid therapy allowed as replacement therapy only
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
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At least 30 days since prior investigational therapy
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At least 30 days since prior anticancer therapy
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No prior systemic therapy for prostate cancer (except hormonal therapy)
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No prior anti-EGFr therapy
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Concurrent antihypercalcemic treatment allowed in the presence of elevated calcium levels but not as cancer therapy for bone disease
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No other concurrent anti-EGFr therapy
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No other concurrent anticancer therapy
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No other concurrent investigational therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1738 |
2 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
Investigators
- Principal Investigator: Arie Belldegrun, MD, FACS, Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000269889
- UCLA-0206074
- ABX-0301