Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT02979977|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : August 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Cancers of the Head and Neck||Drug: cetuximab Drug: afatinib||Phase 2|
This study will be a multicenter, single-arm, open-label Phase II trial. Patients with advanced squamous cell carcinoma of the head and neck, who are previously treated with a platinum based regimen or with immune checkpoint inhibitor therapy or both, will be eligible for participation on the study. After a baseline evaluation and biopsy (where feasible), they will be treated with weekly/bi-weekly intravenous cetuximab and daily oral afatinib. Biopsy will be repeated where feasible after 4 weeks (window of +1 week) on therapy and again at disease progression or end of treatment.
Treatment will continue until disease progression or development of Grade 3 or higher drug related toxicities that fail to resolve to Grade 2 despite appropriate supportive care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Arm Phase II Trial of Dual Inhibition of EGFR With Afatinib and Cetuximab With Correlative Studies in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck|
|Actual Study Start Date :||March 24, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: All subjects
Advanced squamous cell carcinoma of the head and neck region, having previously been treated on a platinum based regimen or with an immune checkpoint inhibitor. Subjects will receive Afatinib dose 30 mg per day and weekly/bi-weekly intravenous cetuximab.
30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
Other Name: Erbitux
Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
Other Name: GIOTRIF or GILOTRIF
- Tumor shrinkage [ Time Frame: Disease progression or end of treatment (up to 2 years) ]Objective Response Rate (Complete Response + Partial Response), defined by tumor shrinkage (mm), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Progression-free survival in weeks [ Time Frame: 1 year follow-up ]We will use Kaplan-Meier survival analysis to estimate the median PFS in the cohort.
- Overall survival in months [ Time Frame: 1 year follow-up ]Measured by a monthly phone calls. We will use Kaplan-Meier survival analysis to estimate the median and OS in the cohort.
- Duration of response in weeks [ Time Frame: 1 year follow-up ]
- Toxicity assessed with National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 2.5 years ]
- Exploratory biomarker analysis [ Time Frame: Up to 2 years ]Analysis of tumor-tissue from biopsies obtained at baseline, after four weeks of treatment with the combination, and again at disease progression or end of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979977
|Contact: Alexander Hoslet, CCRP||203-785-5573||Alexander.firstname.lastname@example.org|
|United States, Connecticut|
|Yale Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06520-8028|
|Contact: Clinical Trials Office 203-785-5702|
|Principal Investigator: Aarti Bhatia, MD|
|Principal Investigator:||Aarti Bhatia, MD, MPH||Yale University|