Study on Dual Inhibition of EGFR with Afatinib and Cetuximab for Advanced Head and Neck Squamous Cell Cancer
Sponsor: Yale University
ClinicalTrials ID:NCT02979977
This clinical trial is testing a combination of two drugs, afatinib and cetuximab, to see if they can effectively treat advanced squamous cell cancer of the head and neck in patients who have already received certain treatments.
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Program Overview
This study is for patients with advanced squamous cell cancer of the head and neck that has come back or spread after previous treatments. It aims to find out if a combination of two drugs, afatinib and cetuximab, can help control the cancer. Participants will receive these medications and be monitored to see how well the treatment works and if there are any side effects.
Description
This clinical trial is a Phase II study, meaning it focuses on the effectiveness and safety of the treatment. It is open to patients with advanced squamous cell cancer of the head and neck who have already been treated with a platinum-based chemotherapy or an immune checkpoint inhibitor. Participants will receive cetuximab through an IV weekly or bi-weekly and take afatinib orally every day. The treatment will continue until the cancer progresses or side effects become too severe. Biopsies may be taken before starting the treatment, after four weeks, and at the end of the treatment to assess the cancer's response.
Eligibility Criteria
Inclusion Criteria
- Have advanced squamous cell cancer of the head and neck that cannot be cured with surgery.
- Previously treated with a platinum-based chemotherapy or an immune checkpoint inhibitor.
- Cancer has progressed within 6 months after completing platinum-based treatment.
- Previous use of cetuximab is allowed if it was part of initial treatment.
- Have measurable cancer that can be tracked with scans.
- Be in good overall health with an ECOG performance status of 2 or less.
- Have adequate blood counts and organ function based on specific tests.
- Women of childbearing potential must have a negative pregnancy test.
- Must be able to understand and sign a consent form agreeing to participate.
Exclusion Criteria
- Have previously taken certain other cancer drugs like erlotinib or gefitinib.
- Have had radiation therapy within 2 weeks before starting the study.
- Have an allergy to afatinib or its ingredients.
- Women who are pregnant or breastfeeding, or planning to become pregnant.
- Have other active cancers being treated with systemic therapy.
- Have significant lung disease or untreated viral infections like hepatitis or HIV.
- Have untreated brain metastases unless treated and stable.
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