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Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cisplatin
Standard Fractionation Radiotherapy
Panitumumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, panitumumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy)
  • You must be at least 18 years of age
  • Your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant
  • You must have measurable disease

Exclusion Criteria:

  • Cancer of the nasopharynx, sinus, salivary gland or skin
  • History of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer
  • Previous treatment with anti-endothelial growth factor receptor (EGFr) antibody therapy or EGFr inhibitors
  • Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study
  • Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening
  • History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis)
  • Major surgery within 28 days of screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Panitumumab Plus Chemoradiation

    Chemoradiotherapy Alone

    Arm Description

    Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.

    Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.

    Outcomes

    Primary Outcome Measures

    Local Regional Control Rate at 2 Years
    In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.

    Secondary Outcome Measures

    Local Regional Control Rate at 6 Months and 12 Months
    Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
    Duration of Local-regional Control
    Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.
    Progression-Free Survival
    Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date.
    Overall Survival
    Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.
    Percentage of Participants With an Objective Response at 6 Months
    Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions.
    Percentage of Participants With a Complete Response at 6 Months
    Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.

    Full Information

    First Posted
    July 12, 2007
    Last Updated
    September 20, 2018
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00500760
    Brief Title
    Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer
    Official Title
    A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2007 (Actual)
    Primary Completion Date
    March 29, 2011 (Actual)
    Study Completion Date
    April 26, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer, Squamous Cell Carcinoma
    Keywords
    Head and Neck Cancer, panitumumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    153 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Panitumumab Plus Chemoradiation
    Arm Type
    Experimental
    Arm Description
    Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.
    Arm Title
    Chemoradiotherapy Alone
    Arm Type
    Active Comparator
    Arm Description
    Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Administered intravenously (IV; in a vein)
    Intervention Type
    Radiation
    Intervention Name(s)
    Standard Fractionation Radiotherapy
    Intervention Description
    70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)
    Intervention Type
    Drug
    Intervention Name(s)
    Panitumumab
    Other Intervention Name(s)
    Vectibix®
    Intervention Description
    Administered intravenously
    Primary Outcome Measure Information:
    Title
    Local Regional Control Rate at 2 Years
    Description
    In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Local Regional Control Rate at 6 Months and 12 Months
    Description
    Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
    Time Frame
    6 months and 12 months
    Title
    Duration of Local-regional Control
    Description
    Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.
    Time Frame
    From first dose up to 37 months
    Title
    Progression-Free Survival
    Description
    Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date.
    Time Frame
    From first dose date to 37 months
    Title
    Overall Survival
    Description
    Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.
    Time Frame
    From first dose date up to 37 months
    Title
    Percentage of Participants With an Objective Response at 6 Months
    Description
    Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions.
    Time Frame
    6 months
    Title
    Percentage of Participants With a Complete Response at 6 Months
    Description
    Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy) You must be at least 18 years of age Your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant You must have measurable disease Exclusion Criteria: Cancer of the nasopharynx, sinus, salivary gland or skin History of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer Previous treatment with anti-endothelial growth factor receptor (EGFr) antibody therapy or EGFr inhibitors Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) Major surgery within 28 days of screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25596660
    Citation
    Mesia R, Henke M, Fortin A, Minn H, Yunes Ancona AC, Cmelak A, Markowitz AB, Hotte SJ, Singh S, Chan AT, Merlano MC, Skladowski K, Zhang A, Oliner KS, VanderWalde A, Giralt J. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):208-20. doi: 10.1016/S1470-2045(14)71198-2. Epub 2015 Jan 15.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer

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