Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00113347|
Recruitment Status : Completed
First Posted : June 8, 2005
Last Update Posted : February 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Erlotinib Drug: Docetaxel Radiation: Radiation Therapy||Phase 1|
Hide Detailed Description
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 weeks.
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 treatment.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Erlotinib + Docetaxel
Erlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m^2 or 20 mg/m^2 intravenously with Concomitant Boost Radiation to Head/Neck
Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
15 mg/m^2 or 20 mg/m^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
Other Name: Taxotere
Radiation: Radiation Therapy
Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.
- Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation [ Time Frame: 6 weeks of treatment, followed ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113347
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bonnie S. Glisson, MD||M.D. Anderson Cancer Center|