Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054574

Purpose

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	Intervention	Phase
Prostate Cancer	Biological: panitumumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Panitumumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2002

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054574

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1738
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Arie Belldegrun, MD, FACS

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000269889, UCLA-0206074, ABX-0301
Study First Received:	February 5, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00054574 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009