| Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Closed | 18 and over | CDR0000269889
UCLA-0206074, ABX-0301, NCT00054574 |
Trial Description
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. Further Study Information 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 Performance status Life expectancy 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 - 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 Chemotherapy 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 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 Contact Information
Trial Lead Organizations/Sponsors Jonsson Comprehensive Cancer Center at UCLA National Cancer Institute
| Arie Belldegrun |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00054574
Information obtained from ClinicalTrials.gov on October 19, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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