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Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

Phase 1
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

OSI-774 (also known as Erlotinib or Tarceva) is a drug that helps to block the activity of
an enzyme that is believed to play an important role in cell growth. It is hoped that
blocking this enzyme will slow tumor growth. Docetaxel (Taxotere) is a commonly used
chemotherapy drug. Docetaxel is designed to target and destroy cancer cells.

Before beginning treatment, you will have a complete physical exam. You will also have
routine blood (about 4 teaspoons) and urine tests, a chest x-ray or CT scan, and an
electrocardiogram (ECG - test to measure the electrical activity of the heart). You will
have a dental exam performed by a dentist. Women who are able to have children must have a
negative pregnancy test (blood or urine). You will also have either a CT scan or a MRI to
measure your disease. You may have a bone scan and/or CT scans of your abdomen and chest if
your doctor thinks it is necessary for your care.

You will have a swallowing evaluation. The swallowing evaluation involves drinking barium
and other liquids of varying thickness while fluoroscopy (like an x-ray movie) is done to
evaluate swallowing function. You will also complete a questionnaire that asks questions
about quality of life issues. The questionnaire should take about 10 minutes to complete.

In this study you will receive radiation therapy 5 days per week (Monday through Friday) for
6 weeks. You will not receive radiation therapy on weekends. For the first 3 weeks of
treatment you will receive radiation once a day. Starting on the 4th week of treatment, you
will receive radiation treatment twice a day. The treatments will be at least 6 hours
apart. You will receive these twice daily radiation treatments Monday through Friday for 3

On your first day of radiation treatment you will also receive your first dose of docetaxel.
You will receive docetaxel by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of

Beginning on Day 2 of treatment, you will begin taking OSI-774 by mouth. You will take
OSI-774 once a day in the morning with up to 7 ounces of water either 2 hours after or 1
hour before eating. If you are unable to swallow the OSI-774, you may dissolve it in
distilled water and take it through a feeding tube. You will take OSI-774 every day while
on treatment except on days on which you receive docetaxel (i.e., Days 1, 8, 15, and 22).
You should not take OSI-774 on days you receive a docetaxel infusion.

Participants will enter this study in groups of 3. The doses of both OSI-774 and docetaxel
will be increased after each group. Six patients will be studied at the dose level that is
estimated to be the highest safe dose.

While receiving treatment on this study, you will be examined at least once a week. You
will also have weekly blood tests (2-4 teaspoons). At the end of treatment, you will have
another CT scan or MRI to measure your disease. You will also have a complete physical exam
and blood tests (4 teaspoons). You may be taken off study if your disease gets worse or
intolerable side effects occur.

After completing treatment, you will have a follow-up visit every 3 months for 2 years, then
every 4 months during Year 3, and every 6 months during Years 4 and 5. These visits will
include a medical history and physical exam. A CT or MRI study and blood work (2-4
teaspoons) may also be done. You will have swallowing evaluations at 3 and 12 months
following treatment, and then once yearly through year 5. When you have these swallowing
evaluations, you will also be asked to complete a short questionnaire about swallowing. The
questionnaire will take about 10 minutes to complete.

This is an investigational study. OSI-774 is approved by the FDA for treatment of non-small
cell lung cancer. Docetaxel is approved by the FDA for treatment of lung cancer and breast
cancer. Their use together in this study with radiation treatment is experimental. Up to 24
patients are expected to take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients with histological proof (from the primary lesion and/or lymph nodes) of
squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.

2. Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0

3. Patients must have a Karnofsky performance status of >= 70

4. Age >/= 18 years

5. No hematogenous metastatic disease

6. Patients should have adequate bone marrow function defined as an absolute peripheral
granulocyte count (AGC) of > 1500 cells/mm**3 and platelet count of > 100,000
cells/mm**3; adequate hepatic function with total bilirubin <= Upper Limit of Normal
(ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or
SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is
normal. Alkaline phosphatase may be up to 4 * ULN if aspartate aminotransferase (AST
or SGOT) and alanine aminotransferase (ALT or SGPT) are normal. Patients who have
SGPT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not eligible.

7. Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl
male = (140 - age) * (weight as kg)/serum Cr * 72 CrCl female = 0.85 * (CrCl male)

8. Patients must not have received previous surgery, other than diagnostic biopsy, or
radiation, for this cancer. Patients may have received neoadjuvant chemotherapy which
must have been completed > 3 weeks from beginning therapy on this trial.

9. Patients with a history of non-melanoma skin cancer, or other previous malignancies
treated 5 years or more prior to the current tumor from which the patient has
remained continually disease-free, are eligible.

10. Patients must sign a study-specific informed consent form.

11. Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for 6 months thereafter. 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.

Exclusion Criteria:

1. Histology other than squamous cell carcinoma.

2. Evidence of metastases (below the clavicle or distant) by clinical or radiographic

3. Karnofsky performance status < 70

4. Prior therapy with inhibitors of epidermal growth factor receptor (EGFR)

5. Prior radiotherapy to the head and neck

6. Patients with simultaneous primaries

7. Patients with a past history of malignancy (excluding non melanoma skin cancers, and
cancers treated > 5 years prior for which patient remains continuously disease free).

8. Pregnant/breast-feeding women are ineligible.

9. Patients refusing or unable to sign the informed consent.

10. Patients with pre-existing peripheral neuropathy NCI Common Toxicity Criteria (CTC)
grade 2 or worse.

11. Patients with a history of severe hypersensitivity reaction to Taxotere® and/or
Polysorbate 80 must be excluded.

12. Patients may not use ketoconazole, St. John's Wort, or erythromycin.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation

Outcome Description:

MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.

Outcome Time Frame:

6 weeks of treatment, followed

Safety Issue:


Principal Investigator

Bonnie S. Glisson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

April 2011

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Erlotinib
  • Docetaxel
  • Radiation
  • Radiotherapy
  • Concomitant Boost Radiation
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030