Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
| Sponsoren |
Hauptsponsor: Jonsson Comprehensive Cancer Center |
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| Quelle | Jonsson Comprehensive Cancer Center | ||||||
| Kurze Zusammenfassung | 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. |
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| detaillierte Beschreibung | 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. |
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| Gesamtstatus | Completed | ||||||
| Anfangsdatum | November 2002 | ||||||
| Fertigstellungstermin | February 2004 | ||||||
| Primäres Abschlussdatum | September 2003 | ||||||
| Phase | Phase 2 | ||||||
| Studientyp | Interventional | ||||||
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| Intervention |
Interventionsart: Biological Interventionsname: panitumumab |
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| Teilnahmeberechtigung |
Kriterien:
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 Geschlecht: Male Mindestalter: 18 Years Maximales Alter: 120 Years Gesunde Freiwillige: No |
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| Insgesamt offiziell |
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| Ort |
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| Standort Länder |
United States |
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| Überprüfungsdatum |
August 2012 |
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| Verantwortliche Partei |
Art: Sponsor |
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| Schlüsselwörter | |||||||
| Hat den Zugriff erweitert | No | ||||||
| Bedingung Durchsuchen | |||||||
| Studiendesign Info |
Hauptzweck: Treatment Maskierung: None (Open Label) |
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