Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411632
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2006-12-12
Brief Title:
BATTLE Program Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Erlotinib Tarceva in Combination With Bexarotene Targretin in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2020-01
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 evaluate the effectiveness of Tarceva OSI-774 erlotinib hydrochloride in combination with Targretin bexarotene in treating NSCLC The safety of this treatment will also be studied as well as the treatments effect on different cells in the body and the participants overall response
Detailed Description:
Erlotinib hydrochloride is designed to help block the activity of an enzyme that is believed to play an important role in cell growth Researchers want to find out if blocking these enzymes will slow tumor growth Bexarotene is designed to control cancer cell growth and division
In order to enroll in this study you must also be enrolled in Protocol 2005-0823 NCT00409968 A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer Protocol 2005-0823 NCT00409968 is the screening study in a group of studies called the BATTLE program Participants in Protocol 2005-0823NCT00409968 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 and bexarotene by mouth once a day Erlotinib hydrochloride 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 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
Bexarotene capsules should be taken with or immediately after a meal If you miss a dose take it as soon as possible with food However if it is nearly time for your next dose skip the missed dose and continue your dose schedule as before
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 medication anti-nausea medications should be used
The erlotinib hydrochloride tablets and bexarotene capsules should be stored at room temperature Bexarotene capsules should not be stored near heating devices high temperatures or humidity or where children or pets have access to them Bexarotene capsules should be protected from sunlight
Every 4 weeks 1 cycle your medical history will be recorded and you will have a physical exam including measurement of vital signs blood pressure pulse temperature and breathing rate and weight You will have routine blood tests about 2 teaspoons and a performance status evaluation questions about your ability to perform everyday activities You will have blood drawn about 1-2 teaspoons to check you thyroid function You will also have blood drawn about 1-2 teaspoons to check your lipid profile weekly for the first 4 weeks and then every cycle after that Your study doctor will also ask you about any medications you are taking and your smoking history
Every 2 cycles your 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 Coumadin 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 and bexarotene 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
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
This is an investigational study Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma CTCL Their use together in this study is investigational Up to 72 patients will take part in this multicenter 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 NCT00409968 A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer Protocol 2005-0823 NCT00409968 is the screening study in a group of studies called the BATTLE program Participants in Protocol 2005-0823NCT00409968 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 and bexarotene by mouth once a day Erlotinib hydrochloride 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 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
Bexarotene capsules should be taken with or immediately after a meal If you miss a dose take it as soon as possible with food However if it is nearly time for your next dose skip the missed dose and continue your dose schedule as before
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 medication anti-nausea medications should be used
The erlotinib hydrochloride tablets and bexarotene capsules should be stored at room temperature Bexarotene capsules should not be stored near heating devices high temperatures or humidity or where children or pets have access to them Bexarotene capsules should be protected from sunlight
Every 4 weeks 1 cycle your medical history will be recorded and you will have a physical exam including measurement of vital signs blood pressure pulse temperature and breathing rate and weight You will have routine blood tests about 2 teaspoons and a performance status evaluation questions about your ability to perform everyday activities You will have blood drawn about 1-2 teaspoons to check you thyroid function You will also have blood drawn about 1-2 teaspoons to check your lipid profile weekly for the first 4 weeks and then every cycle after that Your study doctor will also ask you about any medications you are taking and your smoking history
Every 2 cycles your 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 Coumadin 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 and bexarotene 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
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
This is an investigational study Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma CTCL Their use together in this study is investigational Up to 72 patients will take part in this multicenter study All will be enrolled at M D Anderson
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-06-1-0303 | OTHER | Department of Defense | None |
| NCI-2012-02089 | REGISTRY | None | None |