Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410059
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2006-12-08
Brief Title:
BATTLE Program Erlotinib in Previously Treated Subjects With Advanced NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Open Label Study of Erlotinib Tarceva in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
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 erlotinib hydrochloride OSI-774 Tarceva can help to control NSCLC The safety of this drug will also be studied as well as the drugs effect on different cells in the body and the participants overall response
Detailed Description:
Erlotinib hydrochloride is designed to block the activity of an enzyme found on the surface of many tumor cells that may slow tumor growth
In order to enroll in this study you must also be enrolled in Protocol 2005-0823 A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program Participants in Protocol 2005-0823 are assigned to one of the research studies The results of your tumor analysis helped the study doctor determine to assign you to this particular research study
While on study you will take erlotinib hydrochloride by mouth once a day Tablets should be taken preferably in the morning 1 hour before or 2 hours after a meal with no more than 7 ounces of water If you are unable to swallow tablets you may dissolve the tablets in distilled water If you forget to take a dose the last missed dose should be taken as soon as you remember as long as it is at least 12 hours before the next dose is due to be taken The next day you should take the scheduled dose at the usual time Every attempt should be made to keep from vomiting the medication for at least 30 minutes after taking it For example if you feel nauseated before or after taking the erlotinib anti-nausea medications should be used The dose of erlotinib hydrochloride may be repeated if vomiting occurs within 30 minutes of taking the tablet Four 4 weeks is considered 1 treatment cycle
Every 4 weeks your complete medical history will be recorded and you will have a physical exam including measurement of vital signs blood pressure pulse temperature breathing rate and weight You will have blood drawn about 2 teaspoons for routine tests You will have a performance status evaluation questions about your ability to perform everyday activities Your study doctor will ask you about any medications you are taking and your smoking history Every 2 cycles the tumor will be evaluated by chest x-ray and computed tomography CT or magnetic resonance imaging MRI scans to evaluate the status of the disease If you are taking warfarin you will have blood drawn about 1-2 teaspoons to check your blood clotting function weekly for the first 5 weeks of treatment and then every cycle after that
You may continue receiving erlotinib hydrochloride for as long as the cancer responds to study treatment Your doctor may decide to take you off this study if you experience intolerable side effects your medical condition gets worse or you are unable to comply with study requirements If you stop study treatment you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program You should discuss this with your doctor
After you have stopped taking the study treatment you will have a physical exam including measurement of vital signs Blood about 2 teaspoons and urine will be collected for routine tests You will also have blood drawn about 1-2 teaspoons to check your blood clotting function You will have a performance status evaluation a chest x-ray and a CT or MRI scan Following this evaluation you will be contacted by telephone every 3 months for up to 3 years to see how you are doing
You have the right to leave the study at any time If you choose to stop participating in this study you should contact the study chair andor research nurse Your doctor may decide to take you off this study if your medical condition gets worse andor you are unable to comply with study requirements
This is an investigational study Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed Up to 72 patients will take part in this study All will be enrolled at M D Anderson
In order to enroll in this study you must also be enrolled in Protocol 2005-0823 A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program Participants in Protocol 2005-0823 are assigned to one of the research studies The results of your tumor analysis helped the study doctor determine to assign you to this particular research study
While on study you will take erlotinib hydrochloride by mouth once a day Tablets should be taken preferably in the morning 1 hour before or 2 hours after a meal with no more than 7 ounces of water If you are unable to swallow tablets you may dissolve the tablets in distilled water If you forget to take a dose the last missed dose should be taken as soon as you remember as long as it is at least 12 hours before the next dose is due to be taken The next day you should take the scheduled dose at the usual time Every attempt should be made to keep from vomiting the medication for at least 30 minutes after taking it For example if you feel nauseated before or after taking the erlotinib anti-nausea medications should be used The dose of erlotinib hydrochloride may be repeated if vomiting occurs within 30 minutes of taking the tablet Four 4 weeks is considered 1 treatment cycle
Every 4 weeks your complete medical history will be recorded and you will have a physical exam including measurement of vital signs blood pressure pulse temperature breathing rate and weight You will have blood drawn about 2 teaspoons for routine tests You will have a performance status evaluation questions about your ability to perform everyday activities Your study doctor will ask you about any medications you are taking and your smoking history Every 2 cycles the tumor will be evaluated by chest x-ray and computed tomography CT or magnetic resonance imaging MRI scans to evaluate the status of the disease If you are taking warfarin you will have blood drawn about 1-2 teaspoons to check your blood clotting function weekly for the first 5 weeks of treatment and then every cycle after that
You may continue receiving erlotinib hydrochloride for as long as the cancer responds to study treatment Your doctor may decide to take you off this study if you experience intolerable side effects your medical condition gets worse or you are unable to comply with study requirements If you stop study treatment you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program You should discuss this with your doctor
After you have stopped taking the study treatment you will have a physical exam including measurement of vital signs Blood about 2 teaspoons and urine will be collected for routine tests You will also have blood drawn about 1-2 teaspoons to check your blood clotting function You will have a performance status evaluation a chest x-ray and a CT or MRI scan Following this evaluation you will be contacted by telephone every 3 months for up to 3 years to see how you are doing
You have the right to leave the study at any time If you choose to stop participating in this study you should contact the study chair andor research nurse Your doctor may decide to take you off this study if your medical condition gets worse andor you are unable to comply with study requirements
This is an investigational study Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed Up to 72 patients will 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-06-1-0303 | OTHER | DOD | None |
| NCI-2012-02083 | REGISTRY | None | None |