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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00500760
First received: July 12, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Squamous Cell Carcinoma
Drug: Cisplatin
Radiation: Standard Fractionation Radiotherapy
Drug: Panitumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Local Regional Control Rate at 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: From first dose up to 37 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: From first dose date to 37 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: From first dose date up to 37 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 153
Study Start Date: October 2007
Study Completion Date: November 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab Plus Chemoradiation
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.
Drug: Cisplatin
Administered intravenously (IV; in a vein)
Radiation: Standard Fractionation Radiotherapy
70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)
Drug: Panitumumab
Administered intravenously
Other Name: Vectibix®
Active Comparator: Chemoradiotherapy Alone
Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Drug: Cisplatin
Administered intravenously (IV; in a vein)
Radiation: Standard Fractionation Radiotherapy
70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500760

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00500760     History of Changes
Other Study ID Numbers: 20062080
Study First Received: July 12, 2007
Results First Received: February 13, 2014
Last Updated: July 10, 2014
Health Authority: Finland: Lääkelaitos
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Canada: Health Canada
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Italy: Local Ethics Committees
Mexico: COFEPRIS
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration

Keywords provided by Amgen:
Head and Neck Cancer
panitumumab

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014