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Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

Phase 1
18 Years
Open (Enrolling)
Head And Neck Cancer

Thank you

Trial Information

Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

The Study Drug:

Erlotinib is designed to block the activity of a protein found on the surface of many tumor
cells that may control tumor growth and survival. This may stop tumors from growing.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to receive erlotinib at either the standard dose or the high
dose. There is an equal chance of being assigned to either group. If you are assigned to
the high dose group and you are a current smoker, you will receive an even higher daily dose
of erlotinib. Both you and your study doctor will know which group you are in.

Study Drug Administration:

Group 1 will take 1 tablet of erlotinib once a day, every day leading up to surgery.

Group 2 will take 2 tablets once a day, every day leading up to surgery. Depending on your
assigned dose level, the 2 tablets may contain the same drug amount or 2 different drug

Erlotinib should be taken at the same time of day, 1 hour before or 2 hours after a meal.
Each dose should be taken with 8 ounces of water. You should not consume grapefruit or
grapefruit juice while on this study.

If you vomit after taking the medication, you can take another dose again, but only if the
vomited tablet(s) can be seen and counted (in other words, they have not been digested yet).

Study Visits:

Every 2 weeks, you will have a study visit. The following tests and procedures will be

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- You will be asked about any side effects you may be experiencing.

- You will have a CT scan or MRI to check the status of the disease within 1 week before
the surgery.

Within one week before your surgery, you will also have blood (about 2-3 teaspoons) drawn to
check your blood clotting function.

Length of Study:

You will be on study for at least 2-3 weeks up to the day before surgery. You may be on
study for up to 8 weeks if there is a delay in surgery.

After you have completed the study, you will have surgery to remove your tumor. During your
surgery, a sample of your tumor tissue that is already being removed will be collected to
check for biomarkers.


Within 30 days after your surgery, you will be contacted by phone to be asked you about any
side effects you have experienced. The phone call will last about 10 minutes.

This is an investigational study. Erlotinib is FDA approved and commercially available for
the treatment of non-small cell lung cancer and pancreatic cancer (first-line therapy in
combination with gemcitabine). Its use in this study is investigational.

Up to 55 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients with histologically confirmed cancer of the head and neck. Patients with
salivary gland tumors and squamous cell carcinomas of the skin are also eligible.
(Note: Any patient with a diagnosis of aggressive squamous cell carcinoma of the skin
and determined to be surgically resectable will be considered for eligibility. These
patients are typically seen in the Head & Neck surgery clinic and decisions for study
consideration will be based on consultations with the department of Head & Neck

2. The patient must have biopsy-accessible disease.

3. Patients must be surgical candidates (either definitive or palliative setting).

4. Patients may have received prior therapy including cytotoxic chemotherapy (e.g.
platinum drugs and taxanes) and radiation therapy.

5. Patients must have a performance score (ECOG) of 0-2.

6. Patients should have adequate bone marrow function, as defined by peripheral
granulocyte count of >/= 1,000/mm³, and a platelet count of >/= 50,000/mm³.Patients
must have adequate liver function with a bilirubin normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
must be
7. Patients should have adequate renal function (serum creatinine
8. Age >/= 18 years

9. Ability to understand and the willingness to sign a written informed consent document
indicating that they are aware of the investigational nature of the study, in keeping
with institutional policy

10. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Childbearing potential will be defined as women who
have had menses within the past 12 months,who have not had tubal ligation or
bilateral oophorectomy. Should a woman become pregnant or suspect that she is
pregnant while participating in this study,she should inform her treating physician
immediately.The patient,if a man,agrees to use effective contraception or abstinence.

Exclusion Criteria:

1. Patients with prior exposure to small molecule tyrosine kinase inhibitors or
EGFR-targeted antibodies within the past 6 months.

2. Patients for whom, in the opinion of the treating surgeon, the administration of
erlotinib would cause a deleterious delay in surgical treatment.

3. Patients with uncompensated congestive cardiac failure.

4. Patients with an organ allograft.

5. Patients with a serious concurrent infection or illness including, but not limited
to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that could
limit compliance with study requirements.

6. Female patients who are pregnant or breastfeeding

7. Patients currently on chemotherapy, immunotherapy, or therapy with monoclonal
antibodies or other investigational agents with anti-tumor activity

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effects of erlotinib 150 mg/day (standard dose) + 200 mg/day or 300 mg/day (high-dose) on phosphorylation of AKT protein downstream from EGFR

Outcome Time Frame:

Treatment: 2-3 week period leading up to surgery; Disease reassessment (Imaging studies): 1 week before surgery.

Safety Issue:


Principal Investigator

William N. William Jr., MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head & Neck squamous cell carcinoma
  • HN cancer
  • Surgery
  • Erlotinib
  • Biomarkers
  • Phosphorylation of AKT
  • Head and Neck Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030