Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411671
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2006-12-12
Brief Title:
BATTLE Program Sorafenib in Patients With NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Sorafenib BAY 43-9006 in Chemorefractory Patients With Advanced Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Primary Objective
To determine the 8 week progression-free survival rate ie disease control rate in patients with advanced non-small cell lung cancer NSCLC who have failed at least one prior chemotherapy regimen
Secondary Objective
The secondary objectives of this study will be to
Determine the overall response rate
Determine the overall survival
Determine the time to disease progression
Assess the safetytoxicity of the study treatment
Assess biomarker modulation in the tumor tissue and serum samples from the treatment
Assess plasma and intra-tumor concentrations of study treatment
To determine the 8 week progression-free survival rate ie disease control rate in patients with advanced non-small cell lung cancer NSCLC who have failed at least one prior chemotherapy regimen
Secondary Objective
The secondary objectives of this study will be to
Determine the overall response rate
Determine the overall survival
Determine the time to disease progression
Assess the safetytoxicity of the study treatment
Assess biomarker modulation in the tumor tissue and serum samples from the treatment
Assess plasma and intra-tumor concentrations of study treatment
Detailed Description:
BAY 43-9006 Sorafenib is an experimental agent designed to stop the growth of cancer cells
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 treatment studies The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study
While on study you will take 2 tablets of sorafenib each morning and again each evening Sorafenib should be taken with about 1 cup of water on an empty stomach either 1 hour before a meal or 2 hours after a meal Sorafenib must be swallowed whole without chewing If you feel nauseated before or after taking the medication anti-nausea medications should be used If you miss a dose you should skip it and take the next scheduled dose at the right time Your medication should be stored at room temperature
Every 4 weeks 1 cycle your complete 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 Blood about 2 teaspoons and urine will be drawn for routine tests You will have a performance status evaluation questions about your ability to perform everyday activities and blood drawn about 1-2 teaspoons to check your blood clotting function Your study doctor will also ask you about any medications you are taking and your smoking history You will be asked to record your weekly blood pressure for the first 6 weeks of study treatment The study doctor or research nurse will review the log at each clinic visit
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 6 weeks of treatment and then every cycle after that
You may continue receiving sorafenib 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 or your medical condition gets worse If you stop study treatment you will be allowed to enroll in one 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
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 Sorafenib BAY 43-9006 has been approved by the FDA for treatment of advanced renal cell cancer however its use in this research study is investigational Up to 62 patients will take part in this multicenter study Up to 50 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 treatment studies The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study
While on study you will take 2 tablets of sorafenib each morning and again each evening Sorafenib should be taken with about 1 cup of water on an empty stomach either 1 hour before a meal or 2 hours after a meal Sorafenib must be swallowed whole without chewing If you feel nauseated before or after taking the medication anti-nausea medications should be used If you miss a dose you should skip it and take the next scheduled dose at the right time Your medication should be stored at room temperature
Every 4 weeks 1 cycle your complete 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 Blood about 2 teaspoons and urine will be drawn for routine tests You will have a performance status evaluation questions about your ability to perform everyday activities and blood drawn about 1-2 teaspoons to check your blood clotting function Your study doctor will also ask you about any medications you are taking and your smoking history You will be asked to record your weekly blood pressure for the first 6 weeks of study treatment The study doctor or research nurse will review the log at each clinic visit
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 6 weeks of treatment and then every cycle after that
You may continue receiving sorafenib 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 or your medical condition gets worse If you stop study treatment you will be allowed to enroll in one 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
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 Sorafenib BAY 43-9006 has been approved by the FDA for treatment of advanced renal cell cancer however its use in this research study is investigational Up to 62 patients will take part in this multicenter study Up to 50 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