Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02979977|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Cancers of the Head and Neck||Drug: cetuximab Drug: afatinib||Phase 2|
|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 2018|
|Estimated Study Completion Date :||January 2019|
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 40 mg per day and weekly IV 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. Doses will be administered on the same day of each week (+/- 1 day).
Other Name: ErbituxDrug: afatinib
Patients will take a single oral dose of afatinib each day at a dose of 40 mg. Afatinib dose will not be escalated beyond the 40 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979977
|Contact: Julie Holubfirstname.lastname@example.org|
|Contact: Tara McPartlandemail@example.com|
|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|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Hyunseok Kang, MD, MPH|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Jessica Bauman, MD|
|Principal Investigator:||Aarti Bhatia, MD, MPH||Yale University|