Dual Inhibition of EGFR With Afatinib and Cetuximab in the Treatment of Advanced Squamous Cell Cancers of the Head and Neck

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 24, 2017

Primary Completion Date

January 18, 2025

Study Completion Date

January 31, 2026

Conditions
Squamous Cell Cancers of the Head and Neck
Interventions
DRUG

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).

DRUG

afatinib

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.

Trial Locations (1)

06520-8028

Yale Cancer Center, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Comprehensive Cancer Network

NETWORK

collaborator

Boehringer Ingelheim

INDUSTRY

lead

Yale University

OTHER