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

September 20, 2018 updated by: Amgen

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…

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Leoben, Austria, 8700
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Wien, Austria, 1090
        • Research Site
  • Belgium
      • Brasschaat, Belgium, 2930
        • Research Site
      • Brugge, Belgium, 8000
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Libramont, Belgium, 6800
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Ottignies, Belgium, 1340
        • Research Site
      • Wilrijk, Belgium, 2610
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
      • Znojmo, Czechia, 669 02
        • Research Site
  • France
      • Angers, France, 49933
        • Research Site
      • Lens cedex, France, 62307
        • Research Site
      • Perpignan, France, 66000
        • Research Site
      • Vandoeuvre les Nancy, France, 54511
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 45434
        • Research Site
      • Vilnius, Lithuania, 08660
        • Research Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bratislava, Slovakia, 812 50
        • Research Site
      • Nove Zamky, Slovakia, 940 34
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Research Site
  • Spain
      • Madrid, Spain, 28040
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Research Site
      • Girona, Cataluña, Spain, 17007
        • Research Site
      • L Hospitalet De Llobregat, Cataluña, Spain, 08907
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46009
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Research Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • La Jolla, California, United States, 92037
        • Research Site
      • La Verne, California, United States, 91750
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Santa Cruz, California, United States, 95065
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Denver, Colorado, United States, 80210
        • Research Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
      • Washington, District of Columbia, United States, 20037
        • Research Site
      • Washington, District of Columbia, United States, 20010
        • Research Site
      • Washington, District of Columbia, United States, 20422
        • Research Site
    • Florida
      • Lakeland, Florida, United States, 33805
        • Research Site
      • Miami, Florida, United States, 33176
        • Research Site
      • New Port Richey, Florida, United States, 34655
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • Research Site
      • Griffin, Georgia, United States, 30224
        • Research Site
      • Marietta, Georgia, United States, 30060
        • Research Site
    • Illinois
      • Centralia, Illinois, United States, 62801
        • Research Site
      • Elk Grove Village, Illinois, United States, 60007
        • Research Site
      • Evanston, Illinois, United States, 60201
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Research Site
      • Zion, Illinois, United States, 60099
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Research Site
      • Lexington, Kentucky, United States, 40536
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
      • Louisville, Kentucky, United States, 40202-1703
        • Research Site
      • Paducah, Kentucky, United States, 42003
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Research Site
      • Baltimore, Maryland, United States, 21237
        • Research Site
      • Frederick, Maryland, United States, 21701
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Research Site
      • Lansing, Michigan, United States, 48910
        • Research Site
    • Mississippi
      • Pascagoula, Mississippi, United States, 39581
        • Research Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Research Site
      • Jefferson City, Missouri, United States, 65109
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
      • Saint Louis, Missouri, United States, 63110-1093
        • Research Site
    • Montana
      • Billings, Montana, United States, 59102
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 59074
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • New York
      • Binghamton, New York, United States, 13905
        • Research Site
      • Bronx, New York, United States, 10467
        • Research Site
      • Bronx, New York, United States, 10457
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • New York, New York, United States, 10003
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • Nyack, New York, United States, 10960
        • Research Site
      • Rochester, New York, United States, 14623
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Site
      • Cincinnati, Ohio, United States, 45236
        • Research Site
      • Dayton, Ohio, United States, 45420
        • Research Site
      • Toledo, Ohio, United States, 43614
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Scranton, Pennsylvania, United States, 18510
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Site
      • Charleston, South Carolina, United States, 29406
        • Research Site
      • Greenville, South Carolina, United States, 29615
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Research Site
      • Corpus Christi, Texas, United States, 78405
        • Research Site
      • Corpus Christi, Texas, United States, 78412
        • Research Site
      • Dallas, Texas, United States, 75234
        • Research Site
      • Dallas, Texas, United States, 75201
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • Galveston, Texas, United States, 77555-0158
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Research Site
      • Chesapeake, Virginia, United States, 23320
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Research Site
      • Marshfield, Wisconsin, United States, 54449
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Panitumumab + Docetaxel + Cisplatin
Drug: Cisplatin
chemotherapy arm
Drug: Panitumumab
experimental arm
Drug: Docetaxel
chemotherapy arm
Drug: Cisplatin
experimental arm
Drug: Docetaxel
experimental arm
Other: Arm 2
control
Drug: Cisplatin
chemotherapy arm
Drug: Docetaxel
chemotherapy arm
Drug: Cisplatin
experimental arm
Drug: Docetaxel
experimental arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) During the First-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 67 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) During the First-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 67 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.
Every 6 weeks until disease progression or death, up to 67 months
Rate of Disease Control (RDC) During the First-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 67 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.
Every 6 weeks until disease progression or death, up to 67 months
Duration of Response (DOR) During the First-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 67 months
Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Every 6 weeks until disease progression or death, up to 67 months
Time to Response (TTR) During the First-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 67 months
Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)
Every 6 weeks until disease progression or death, up to 67 months
Overall Survival (OS) for the First-line Treatment
Time Frame: Until death, up to 67 months
Time from the date of randomization to the date of death during the entire study
Until death, up to 67 months
Progression Free Survival (PFS) During the Second-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 57 months
The time from the first dose of panitumumab monotherapy 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 the second-line first dose date (whichever is later) during the second-line treatment phase.
Every 6 weeks until disease progression or death, up to 57 months
Overall Response Rate (ORR) During the Second-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 57 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.
Every 6 weeks until disease progression or death, up to 57 months
Rate of Disease Control (RDC) During the Second-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 57 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.
Every 6 weeks until disease progression or death, up to 57 months
Duration of Response (DOR) During the Second-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 57 months
Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Every 6 weeks until disease progression or death, up to 57 months
Time to Response (TTR) During the Second-line Treatment Phase
Time Frame: Every 6 weeks until disease progression or death, up to 57 months
Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)
Every 6 weeks until disease progression or death, up to 57 months
Overall Survival (OS) for the Second-line Treatment
Time Frame: Until death, up to 57 months
Time from the first dose of panitumumab monotherapy to the date of death during the entire study
Until death, up to 57 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

June 11, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (Estimate)

April 2, 2007

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050236

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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