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

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.

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.

Gesamtstatus Completed
Anfangsdatum November 2002
Fertigstellungstermin February 2004
Primäres Abschlussdatum September 2003
Phase Phase 2
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Biological

Interventionsname: panitumumab

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

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Arie Belldegrun, MD, FACS Principal Investigator Jonsson Comprehensive Cancer Center
Ort
Einrichtung:
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California, 90095-1738, United States
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States
Standort Länder

United States

Überprüfungsdatum

August 2012

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov