PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

NCT ID: NCT00454779

Last Updated: 2018-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-01

Study Completion Date

2014-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Panitumumab + Docetaxel + Cisplatin

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

experimental arm

Cisplatin

Intervention Type DRUG

experimental arm

Docetaxel

Intervention Type DRUG

experimental arm

Arm 2

control

Group Type OTHER

Cisplatin

Intervention Type DRUG

chemotherapy arm

Docetaxel

Intervention Type DRUG

chemotherapy arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cisplatin

chemotherapy arm

Intervention Type DRUG

Panitumumab

experimental arm

Intervention Type DRUG

Docetaxel

chemotherapy arm

Intervention Type DRUG

Cisplatin

experimental arm

Intervention Type DRUG

Docetaxel

experimental arm

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
* Measurable disease by CT scan
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Age: 18 years or older
* Adequate hematologic, renal, metabolic, hepatic \& thyroid function

Exclusion Criteria

* Prior systemic treatment for metastatic and/or recurrent SCCHN
* CNS metastases, or nasopharyngeal carcinoma
* History of interstitial lung disease
* History of another primary cancer
* Any co-morbid disease that would increase risk of toxicity

* Active infection requiring systemic treatment
* Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Tucson, Arizona, United States

Site Status

Research Site

Jonesboro, Arkansas, United States

Site Status

Research Site

Duarte, California, United States

Site Status

Research Site

La Jolla, California, United States

Site Status

Research Site

La Verne, California, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

Santa Cruz, California, United States

Site Status

Research Site

Aurora, Colorado, United States

Site Status

Research Site

Denver, Colorado, United States

Site Status

Research Site

Norwich, Connecticut, United States

Site Status

Research Site

Newark, Delaware, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

Research Site

Lakeland, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

New Port Richey, Florida, United States

Site Status

Research Site

Orlando, Florida, United States

Site Status

Research Site

Athens, Georgia, United States

Site Status

Research Site

Griffin, Georgia, United States

Site Status

Research Site

Marietta, Georgia, United States

Site Status

Research Site

Centralia, Illinois, United States

Site Status

Research Site

Elk Grove Village, Illinois, United States

Site Status

Research Site

Evanston, Illinois, United States

Site Status

Research Site

Park Ridge, Illinois, United States

Site Status

Research Site

Zion, Illinois, United States

Site Status

Research Site

Wichita, Kansas, United States

Site Status

Research Site

Ashland, Kentucky, United States

Site Status

Research Site

Lexington, Kentucky, United States

Site Status

Research Site

Louisville, Kentucky, United States

Site Status

Research Site

Louisville, Kentucky, United States

Site Status

Research Site

Paducah, Kentucky, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Frederick, Maryland, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Ann Arbor, Michigan, United States

Site Status

Research Site

Lansing, Michigan, United States

Site Status

Research Site

Pascagoula, Mississippi, United States

Site Status

Research Site

Columbia, Missouri, United States

Site Status

Research Site

Jefferson City, Missouri, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

Billings, Montana, United States

Site Status

Research Site

Omaha, Nebraska, United States

Site Status

Research Site

Henderson, Nevada, United States

Site Status

Research Site

Hackensack, New Jersey, United States

Site Status

Research Site

Binghamton, New York, United States

Site Status

Research Site

Mineola, New York, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Nyack, New York, United States

Site Status

Research Site

Rochester, New York, United States

Site Status

Research Site

Syracuse, New York, United States

Site Status

Research Site

The Bronx, New York, United States

Site Status

Research Site

The Bronx, New York, United States

Site Status

Research Site

Canton, Ohio, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Research Site

Dayton, Ohio, United States

Site Status

Research Site

Toledo, Ohio, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Langhorne, Pennsylvania, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Scranton, Pennsylvania, United States

Site Status

Research Site

Charleston, South Carolina, United States

Site Status

Research Site

Charleston, South Carolina, United States

Site Status

Research Site

Greenville, South Carolina, United States

Site Status

Research Site

Memphis, Tennessee, United States

Site Status

Research Site

Arlington, Texas, United States

Site Status

Research Site

Corpus Christi, Texas, United States

Site Status

Research Site

Corpus Christi, Texas, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

Galveston, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Abingdon, Virginia, United States

Site Status

Research Site

Chesapeake, Virginia, United States

Site Status

Research Site

Morgantown, West Virginia, United States

Site Status

Research Site

Madison, Wisconsin, United States

Site Status

Research Site

Marshfield, Wisconsin, United States

Site Status

Research Site

Graz, , Austria

Site Status

Research Site

Leoben, , Austria

Site Status

Research Site

Linz, , Austria

Site Status

Research Site

Vienna, , Austria

Site Status

Research Site

Brasschaat, , Belgium

Site Status

Research Site

Bruges, , Belgium

Site Status

Research Site

Kortrijk, , Belgium

Site Status

Research Site

Libramont, , Belgium

Site Status

Research Site

Liège, , Belgium

Site Status

Research Site

Ottignies, , Belgium

Site Status

Research Site

Wilrijk, , Belgium

Site Status

Research Site

Brno, , Czechia

Site Status

Research Site

Prague, , Czechia

Site Status

Research Site

Znojmo, , Czechia

Site Status

Research Site

Angers, , France

Site Status

Research Site

Lens, , France

Site Status

Research Site

Perpignan, , France

Site Status

Research Site

Vandœuvre-lès-Nancy, , France

Site Status

Research Site

Kaunas, , Lithuania

Site Status

Research Site

Vilnius, , Lithuania

Site Status

Research Site

San Juan, , Puerto Rico

Site Status

Research Site

Banská Bystrica, , Slovakia

Site Status

Research Site

Bratislava, , Slovakia

Site Status

Research Site

Nové Zámky, , Slovakia

Site Status

Research Site

Prešov, , Slovakia

Site Status

Research Site

Spišská Nová Ves, , Slovakia

Site Status

Research Site

Santander, Cantabria, Spain

Site Status

Research Site

Barcelona, Catalonia, Spain

Site Status

Research Site

Girona, Catalonia, Spain

Site Status

Research Site

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Research Site

Valencia, Valencia, Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Belgium Czechia France Lithuania Puerto Rico Slovakia Spain

References

Explore related publications, articles, or registry entries linked to this study.

Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

Reference Type BACKGROUND

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20050236

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.