Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | February 2013 |
| End Date: | February 2020 |
Phase I Study of Afatinib With Postoperative Radiation Therapy for Intermediate and High Risk Squamous Cancer of the Head and Neck (SCCHN)
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
an investigational drug. Phase I studies also try to define the appropriate dose of the
investigational drug to use for further studies. "Investigational" means that the drug is
still being studied and that research doctors are trying to find out more about it-such as
the safest dose to use and the side effects it may cause.
Afatinib has been studied in other clinical trials of participants with head and neck cancer,
lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research
studies. This is the first clinical trial to study Afatinib in combination with Radiation
Therapy.
The purpose of this study is to determine the safest dose of Afatinib when given in
combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy
for head and neck cancer.
Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by
blocking multiple proteins known to play a role in the growth of cancer cells. Information
from laboratory research studies suggests that this drug may help to make head and neck
cancer cells more sensitive to Radiation Therapy.
The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a
chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the
standard treatment if you have high risk disease. "High risk disease" means that without
additional therapy, there is a high risk that the disease may return. In this study,
participants with high-risk disease will receive Radiation Therapy and Docetaxel and
Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may
return. Radiation Therapy alone is the standard treatment approach for intermediate risk
cancer. In this study, participants with intermediate risk disease will receive Radiation
Therapy and Afatinib.
an investigational drug. Phase I studies also try to define the appropriate dose of the
investigational drug to use for further studies. "Investigational" means that the drug is
still being studied and that research doctors are trying to find out more about it-such as
the safest dose to use and the side effects it may cause.
Afatinib has been studied in other clinical trials of participants with head and neck cancer,
lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research
studies. This is the first clinical trial to study Afatinib in combination with Radiation
Therapy.
The purpose of this study is to determine the safest dose of Afatinib when given in
combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy
for head and neck cancer.
Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by
blocking multiple proteins known to play a role in the growth of cancer cells. Information
from laboratory research studies suggests that this drug may help to make head and neck
cancer cells more sensitive to Radiation Therapy.
The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a
chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the
standard treatment if you have high risk disease. "High risk disease" means that without
additional therapy, there is a high risk that the disease may return. In this study,
participants with high-risk disease will receive Radiation Therapy and Docetaxel and
Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may
return. Radiation Therapy alone is the standard treatment approach for intermediate risk
cancer. In this study, participants with intermediate risk disease will receive Radiation
Therapy and Afatinib.
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.
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
We found this trial at
3
sites
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Annie Chan, MD
Phone: 617-724-1159
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Danielle Margalit, MD, MPH
Phone: 617-632-3591
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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New York, New York 10029
Principal Investigator: Richard Bakst, MD
Phone: 212-241-6464
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