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

NCT00454779 | Completed Phase 2 Results DMC

• 1 other identifier: 20050236
• Study Type: interventional
• Target: 113
• Locations: 9 countries
• Sites: 114

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.

Conditions

Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck

Keywords

SCCHNC; Metastatic; Recurrent

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) During the First-line Treatment Phase

  The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.

  Every 6 weeks until disease progression or death, up to 67 months

Secondary Outcomes (11)

• Overall Response Rate (ORR) During the First-line Treatment Phase

  Every 6 weeks until disease progression or death, up to 67 months

• Rate of Disease Control (RDC) During the First-line Treatment Phase

  Every 6 weeks until disease progression or death, up to 67 months

• Duration of Response (DOR) During the First-line Treatment Phase

  Every 6 weeks until disease progression or death, up to 67 months

• Time to Response (TTR) During the First-line Treatment Phase

  Every 6 weeks until disease progression or death, up to 67 months

• Overall Survival (OS) for the First-line Treatment

  Until death, up to 67 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Panitumumab + Docetaxel + Cisplatin

Drug: Panitumumab; Drug: Cisplatin; Drug: Docetaxel

Arm 2

OTHER

control

Drug: Cisplatin; Drug: Docetaxel

Interventions

Cisplatin DRUG

chemotherapy arm

Arm 2

Panitumumab DRUG

experimental arm

Arm 1

Docetaxel DRUG

chemotherapy arm

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (114)

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Tucson, Arizona, 85715, United States

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Jonesboro, Arkansas, 72401, United States

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Duarte, California, 91010, United States

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La Jolla, California, 92037, United States

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La Verne, California, 91750, United States

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Los Angeles, California, 90095, United States

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Santa Cruz, California, 95065, United States

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Aurora, Colorado, 80045, United States

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Denver, Colorado, 80210, United States

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Norwich, Connecticut, 06360, United States

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Newark, Delaware, 19713, United States

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Washington D.C., District of Columbia, 20007, United States

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Washington D.C., District of Columbia, 20010, United States

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Washington D.C., District of Columbia, 20037, United States

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Washington D.C., District of Columbia, 20422, United States

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Lakeland, Florida, 33805, United States

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Miami, Florida, 33176, United States

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New Port Richey, Florida, 34655, United States

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Orlando, Florida, 32806, United States

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Athens, Georgia, 30607, United States

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Griffin, Georgia, 30224, United States

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Marietta, Georgia, 30060, United States

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Centralia, Illinois, 62801, United States

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Elk Grove Village, Illinois, 60007, United States

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Evanston, Illinois, 60201, United States

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Park Ridge, Illinois, 60068, United States

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Zion, Illinois, 60099, United States

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Wichita, Kansas, 67214, United States

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Ashland, Kentucky, 41101, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202-1703, United States

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Louisville, Kentucky, 40202, United States

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Paducah, Kentucky, 42003, United States

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Baltimore, Maryland, 21204, United States

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Baltimore, Maryland, 21237, United States

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Frederick, Maryland, 21701, United States

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Boston, Massachusetts, 02114, United States

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Ann Arbor, Michigan, 48106-0995, United States

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Lansing, Michigan, 48910, United States

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Pascagoula, Mississippi, 39581, United States

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Columbia, Missouri, 65201, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63110-1093, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59102, United States

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Omaha, Nebraska, 68114, United States

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Henderson, Nevada, 59074, United States

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Hackensack, New Jersey, 07601, United States

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Binghamton, New York, 13905, United States

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Mineola, New York, 11501, United States

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New York, New York, 10003, United States

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New York, New York, 10032, United States

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Nyack, New York, 10960, United States

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Rochester, New York, 14623, United States

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Syracuse, New York, 13210, United States

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The Bronx, New York, 10457, United States

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The Bronx, New York, 10467, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45236, United States

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Dayton, Ohio, 45420, United States

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Toledo, Ohio, 43614, United States

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Oklahoma City, Oklahoma, 73104, United States

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Langhorne, Pennsylvania, 19047, United States

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Philadelphia, Pennsylvania, 19107, United States

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Scranton, Pennsylvania, 18510, United States

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Charleston, South Carolina, 29406, United States

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Charleston, South Carolina, 29425, United States

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Greenville, South Carolina, 29615, United States

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Memphis, Tennessee, 38120, United States

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Arlington, Texas, 76012, United States

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Corpus Christi, Texas, 78405, United States

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Corpus Christi, Texas, 78412, United States

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Dallas, Texas, 75201, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75234, United States

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Galveston, Texas, 77555-0158, United States

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San Antonio, Texas, 78229, United States

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Abingdon, Virginia, 24211, United States

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Chesapeake, Virginia, 23320, United States

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Morgantown, West Virginia, 26506, United States

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Madison, Wisconsin, 53792, United States

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Marshfield, Wisconsin, 54449, United States

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Graz, 8036, Austria

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Leoben, 8700, Austria

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Linz, 4010, Austria

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Vienna, 1090, Austria

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Brasschaat, 2930, Belgium

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Bruges, 8000, Belgium

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Kortrijk, 8500, Belgium

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Libramont, 6800, Belgium

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Liège, 4000, Belgium

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Ottignies, 1340, Belgium

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Wilrijk, 2610, Belgium

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Brno, 656 53, Czechia

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Prague, 150 06, Czechia

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Znojmo, 669 02, Czechia

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Angers, 49933, France

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Lens, 62307, France

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Perpignan, 66000, France

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Vandœuvre-lès-Nancy, 54511, France

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Kaunas, 45434, Lithuania

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Vilnius, 08660, Lithuania

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San Juan, 00935, Puerto Rico

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Banská Bystrica, 974 01, Slovakia

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Bratislava, 812 50, Slovakia

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Nové Zámky, 940 34, Slovakia

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Prešov, 080 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Santander, Cantabria, 39008, Spain

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Barcelona, Catalonia, 08025, Spain

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Girona, Catalonia, 17007, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Valencia, Valencia, 46009, Spain

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Madrid, 28040, Spain

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Related Publications (1)

• 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.

  BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence

Interventions

Cisplatin; Panitumumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: January 1, 2007
• Primary Completion: June 11, 2012
• Study Completion: January 1, 2014
• Last Updated: October 17, 2018
• Results First Posted: February 7, 2014

Record last verified: 2018-09

Locations

BE (7); LI (2); SL (5); US (82); FR (4); CZ (3); AU (4); ES (6); PR (1)