Clinical trial NCT00500760: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma
Keywords: Head and Neck Cancer
panitumumab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-07-13
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Local Regional Control Rate at 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Local Regional Control Rate at 6 Months and 12 Months
timeFrame: 6 months and 12 months
measure: Duration of Local-regional Control
timeFrame: From first dose up to 37 months
measure: Progression-Free Survival
timeFrame: From first dose date to 37 months
measure: Overall Survival
timeFrame: From first dose date up to 37 months
measure: Percentage of Participants With an Objective Response at 6 Months
timeFrame: 6 months
measure: Percentage of Participants With a Complete Response at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.