Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076310
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2004-01-20
Brief Title:
OSI-774CisplatinTaxotere in Head Neck Squamous Cell Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 learn if giving the new drug Tarceva OSI-774 in combination with Platinol cisplatin and Taxotere docetaxel is effective in the treatment of metastatic or recurrent head and neck cancer The safety of this treatment will also be studied
Detailed Description:
OSI-774 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 these enzymes will slow tumor growth Both cisplatin and docetaxel are commonly used chemotherapy drugs These drugs are designed to target and destroy cancer cells
Before the study you will have a physical exam blood tests around 2 teaspoons and an electrocardiogram ECG - a test that measures the electrical activity of the heart You will also have a chest x-ray and a CT scan If the diagnosis has not yet been confirmed a biopsy of the tumor may need to be done Women who are able to have children must have a negative blood or urine pregnancy test
During treatment you will take OSI-774 by mouth once a day Once every 3 weeks you will be given docetaxel and cisplatin Docetaxel is given by a continuous infusion into a vein over 1 hour This will be followed by an infusion into a vein of cisplatin over 2 hours Treatment with docetaxel and cisplatin is given every 3 weeks for 18 weeks You will continue to take OSI-774 until your disease worsens until side effects become too severe or until your doctor thinks it is no longer benefiting you
If at any time during the study the disease becomes worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
During the study you will have blood drawn around 2 teaspoons once a week These samples will be used for routine lab tests Every 3 weeks you will have a physical exam and your vital signs and weight will be measured You will also be asked about any side effects you may be experiencing If your doctor feels it is necessary you may have more frequent check-up visits
Every 6 weeks during treatment you will have blood tests around 2 teaspoons and imaging tests The imaging tests include a chest x-ray and a CT scan of the head and neck area You may also have CT scans of other areas of the body These tests are being done to check on the status of the disease
You may continue receiving OSI-774 for as long as your cancer responds to study treatment If you continue to receive OSI-774 every 3 months you will have a physical exam including measurement of vital signs routine blood tests about 2 teaspoons a performance status test a test looking at the ability to perform everyday activities a chest x-ray and a CT or MRI scan Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens
This is an investigational study OSI-774 is approved by the FDA for treatment of NSCLC in patients who have relapsed Its use in this study is considered investigational Docetaxel and cisplatin are FDA approved and commercially available There will be a total of 50 patients taking part in this study There will be no cost for OSI-774 or for any tests and procedures performed solely for this research study
Before the study you will have a physical exam blood tests around 2 teaspoons and an electrocardiogram ECG - a test that measures the electrical activity of the heart You will also have a chest x-ray and a CT scan If the diagnosis has not yet been confirmed a biopsy of the tumor may need to be done Women who are able to have children must have a negative blood or urine pregnancy test
During treatment you will take OSI-774 by mouth once a day Once every 3 weeks you will be given docetaxel and cisplatin Docetaxel is given by a continuous infusion into a vein over 1 hour This will be followed by an infusion into a vein of cisplatin over 2 hours Treatment with docetaxel and cisplatin is given every 3 weeks for 18 weeks You will continue to take OSI-774 until your disease worsens until side effects become too severe or until your doctor thinks it is no longer benefiting you
If at any time during the study the disease becomes worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
During the study you will have blood drawn around 2 teaspoons once a week These samples will be used for routine lab tests Every 3 weeks you will have a physical exam and your vital signs and weight will be measured You will also be asked about any side effects you may be experiencing If your doctor feels it is necessary you may have more frequent check-up visits
Every 6 weeks during treatment you will have blood tests around 2 teaspoons and imaging tests The imaging tests include a chest x-ray and a CT scan of the head and neck area You may also have CT scans of other areas of the body These tests are being done to check on the status of the disease
You may continue receiving OSI-774 for as long as your cancer responds to study treatment If you continue to receive OSI-774 every 3 months you will have a physical exam including measurement of vital signs routine blood tests about 2 teaspoons a performance status test a test looking at the ability to perform everyday activities a chest x-ray and a CT or MRI scan Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens
This is an investigational study OSI-774 is approved by the FDA for treatment of NSCLC in patients who have relapsed Its use in this study is considered investigational Docetaxel and cisplatin are FDA approved and commercially available There will be a total of 50 patients taking part in this study There will be no cost for OSI-774 or for any tests and procedures performed solely for this research study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None