Clinical trial NCT00454779: PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
Official title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Keywords: SCCHNC
Metastatic
Recurrent
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) During the First-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 67 months
Secondary outcomes:
measure: Overall Response Rate (ORR) During the First-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 67 months
measure: Rate of Disease Control (RDC) During the First-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 67 months
measure: Duration of Response (DOR) During the First-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 67 months
measure: Time to Response (TTR) During the First-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 67 months
measure: Overall Survival (OS) for the First-line Treatment
timeFrame: Until death, up to 67 months
measure: Progression Free Survival (PFS) During the Second-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 57 months
measure: Overall Response Rate (ORR) During the Second-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 57 months
measure: Rate of Disease Control (RDC) During the Second-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 57 months
measure: Duration of Response (DOR) During the Second-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 57 months
measure: Time to Response (TTR) During the Second-line Treatment Phase
timeFrame: Every 6 weeks until disease progression or death, up to 57 months
measure: Overall Survival (OS) for the Second-line Treatment
timeFrame: Until death, up to 57 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Duarte
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: La Verne
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Santa Cruz
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Norwich
country: United States
facility: Research Site
state: Connecticut
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Lakeland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
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state: Florida
city: New Port Richey
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Athens
country: United States
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state: Georgia
city: Griffin
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Centralia
country: United States
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state: Illinois
city: Elk Grove Village
country: United States
facility: Research Site
state: Illinois
city: Evanston
country: United States
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state: Illinois
city: Park Ridge
country: United States
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state: Illinois
city: Zion
country: United States
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state: Illinois
city: Wichita
country: United States
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state: Kansas
city: Ashland
country: United States
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state: Kentucky
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Paducah
country: United States
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state: Kentucky
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Pascagoula
country: United States
facility: Research Site
state: Mississippi
city: Columbia
country: United States
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state: Missouri
city: Jefferson City
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Omaha
country: United States
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state: Nebraska
city: Henderson
country: United States
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state: Nevada
city: Hackensack
country: United States
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state: New Jersey
city: Binghamton
country: United States
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state: New York
city: Bronx
country: United States
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state: New York
city: Bronx
country: United States
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state: New York
city: Mineola
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Nyack
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Canton
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Langhorne
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Scranton
country: United States
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state: Pennsylvania
city: Charleston
country: United States
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state: South Carolina
city: Charleston
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Memphis
country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Galveston
country: United States
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state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Abingdon
country: United States
facility: Research Site
state: Virginia
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Marshfield
country: United States
facility: Research Site
state: Wisconsin
city: Graz
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Libramont
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Praha 5
country: Czechia
facility: Research Site
city: Znojmo
country: Czechia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Lens cedex
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Vandoeuvre les Nancy
country: France
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Spisska Nova Ves
country: Slovakia
facility: Research Site
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Girona
country: Spain
facility: Research Site
state: Cataluña
city: L Hospitalet De Llobregat
country: Spain
facility: Research Site
state: Cataluña
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.