NCT00054574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

10 months

First QC Date

February 5, 2003

Last Update Submit

July 30, 2020

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage I prostate cancerstage II prostate cancerstage III prostate cancer

Interventions

panitumumabBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1738, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Arie Belldegrun, MD, FACS

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

November 1, 2002

Primary Completion

September 1, 2003

Study Completion

February 1, 2004

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(2)