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Phase I Study of Afatinib With Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)

Phase 1
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Phase I Study of Afatinib With Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)

If you are willing to take part in this study you will be asked to undergo some screening
tests and procedures to confirm your eligibility. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if you do not take part in the
research study. If you already had some of these tests and procedures recently, they may or
may not have to be repeated. The tests and procedures include: a review of your medical
history, physical exam, blood samples, urine sample, serum pregnancy test,
electrocardiogram, echocardiogram and an assessment of your disease to find out the extent
of your cancer. If these tests show that you are eligible to participate in the research
study, you may begin the study treatment. If you do not meet the eligibility criteria, you
will not be able to participate in this research study.

We will collect an archive tumor specimen (leftover tissue from your prior surgery or
biopsies) to confirm your cancer diagnosis. Additional tests on the tumor specimen may be
performed as a part of future studies to gain new knowledge about head and neck cancer.

You will receive Afatinib as a pill that you take by mouth for 7 weeks. During the first
week, you will receive Afatinib alone. During the second through seventh weeks, you will
receive Afatinib together with Radiation Therapy OR with Docetaxel and Radiation Therapy.
Docetaxel is given intravenously, once a week during Week 2 through Week 7. Not everyone who
participates in this research study will receive the same dose of the study drug. The dose
you get will depend on the number of participants who have been enrolled in the study before
you and how well they tolerated their doses.

Afatinib needs to be taken on an empty stomach. Specific instructions about this will be
included in the drug diary you will need to complete.

If you take part in this research study, you will receive the same radiation that you would
receive if you were not on the study. The radiation is typically done daily Monday through
Friday for about 6-7 weeks. You will sign a separate consent form with your radiation
oncologist that will outline what to expect with this treatment.

You will be given a physical exam every week during your treatment. You will have a physical
exam and be asked questions about your general health and specific questions about any
problems that you might be having and any medications you may be taking.

You will have blood tests every week during your treatment including chemistry and
hematology tests and a pregnancy test if you are a woman capable of becoming pregnant before
you receive your first infusion of docetaxel.

You will also be asked to return to the clinic one week, four weeks and eight weeks after
finishing your treatment. Most of these visits are part of routine visits after finishing
treatment. If you stop the study early for any reason, you will also have a clinic visit. In
either instance, the following exams and procedures will be performed: physical exam, blood
tests, other tests including an electrocardiogram, MUGA scan or echocardiogram, CT scan and
a PET/CT scan.

Inclusion Criteria:

- Histologically proven diagnosis of squamous cell carcinoma of the head and neck

- Pathology from the primary surgery must be reviewed and finalized at either the
Dana-Farber Cancer Institute/Brigham & Women's Hospital or the pathology department
at any participating institution

- Status post gross total resection with curative intent

- Primary tumor site: oral cavity, oropharynx, larynx, hypopharynx

- Disease must be defined as either high-risk or intermediate risk

- Definition of high-risk: Any of the following high-risk features: positive margins
(defined as tumor at ink), extracapsular extension of lymph node, gross T4a or T4b
primary tumor, any lymph node ≥ 6cm (N3)

- Definition of intermediate-risk: Absence of any high-risk features AND any one of the
following intermediate risk features: Two or more positive lymph nodes involved with
squamous cell carcinoma, single lymph node >3cm and <6cm, perineural invasion,
lymphovascular invasion, Level IV or level V involvement of oral cavity or
oropharyngeal tumors, or T2 oral cavity tumor with >5mm depth of invasion

Exclusion Criteria:

- Prior anti-epidermal growth factor (EGF) or anti-Human Epidermal Growth Factor
Receptor-2 (HER2) therapy

- Prior radiation therapy to the head and neck

- Pregnant or breastfeeding

- Distant metastases

- Receiving other study agents

- History of interstitial lung disease

- Symptomatic peripheral neuropathy

- Active or prior malignancy except non-melanoma skin cancer

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to afatinib or docetaxel

- Cardiac left ventricular dysfunction

- Uncontrolled intercurrent illness

- HIV positive on combination antiretroviral therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The presence or absence of a dose-limiting toxicity at a given dose-level of afatinib.

Outcome Description:

All participants who receive any amount of study drug will be evaluable for toxicity. The primary outcome measure is the incidence of a physician-assessed dose-limiting toxicity (DLT) at a given dose-level of afatinib. Participants will be assessed for a DLT at least once per week during the course of therapy, including the one-week afatinib lead-in period and the 6-7 weeks of radiation therapy. DLT's are defined as the incidence of a severe or life-threatening toxicity (grade 3-4) as defined by the Common Terminology Criteria for Adverse Events Versions 4 (CTCAEv.4) or any afatinib-related toxicity requiring a dose reduction occurring during treatment with afatinib and radiation therapy +/- docetaxel. Participants will continue to be assessed for adverse events for 12 weeks after the completion of therapy.

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Danielle Margalit, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617