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

Amgen153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Head and Neck Cancer Squamous Cell Carcinoma

Interventions

CisplatinDRUG

Administered intravenously (IV; in a vein)

Standard Fractionation RadiotherapyRADIATION

70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)

PanitumumabDRUG

Administered intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 6 months and 12 months

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.

Time frame: From first dose up to 37 months

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.

Data from ClinicalTrials.gov

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