Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113347
Status:
COMPLETED
Last Update Posted:
2012-02-27
First Post:
2005-06-07
Brief Title:
Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy XRT for Head and Neck Squamous Cell Carcinoma HNSCC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer
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 andor 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 ie 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
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 andor 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None