Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410189
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2006-12-08
Brief Title:
BATTLE Program ZD6474 in Previously Treated Subjects With NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Open Label Study of ZD6474 in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2015-03
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 NSCLC who have failed at least one prior chemotherapy regimen
Secondary Objectives
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 NSCLC who have failed at least one prior chemotherapy regimen
Secondary Objectives
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:
ZD6474 is designed to block the formation of new blood vessels The growth of new blood vessels is called angiogenesis Angiogenesis is thought to be important for the growth of tumors beyond a small size Researchers want to find out if ZD6474 will limit new blood vessel growth in the tumor and starve the tumor by limiting blood flow to it
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 treatment study
While on study you will take ZD6474 by mouth each morning ZD6474 is swallowed as a whole tablet The tablet should not be chewed crushed or divided and should be taken with 8 ounces of water and a small amount of food to lessen stomach discomfort You should take ZD6474 at about the same time every day Four 4 weeks is considered 1 treatment cycle If you miss a dose and are unable to take the missed dose on the same day you should take the next scheduled dose and the missed dose will not be made up The dose of study medication may be repeated if vomiting occurs within 30 minutes of taking the study medication
You will have routine blood tests about 2 teaspoons at Weeks 1 2 4 8 12 then every 4 weeks after that You will have an electrocardiogram ECG -- a test that measures the electrical activity of the heart at Weeks 1 2 4 8 12 then every 3 months after that Every 4 weeks your complete medical history will be recorded and you will have a physical exam including measurement of vital signs blood pressure heart rate temperature and breathing rate a performance status evaluation and weight You will also have a routine urine test and your study doctor will 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 you will have blood drawn about 1-2 teaspoons to check your blood clotting function every week You will be asked to bring your unused medication to each clinic visit
You may continue receiving ZD6474 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 andor 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 chest x-ray ECG 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
This is an investigational study ZD6474 is an investigational drug that has been approved by the FDA for research use only 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 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 treatment study
While on study you will take ZD6474 by mouth each morning ZD6474 is swallowed as a whole tablet The tablet should not be chewed crushed or divided and should be taken with 8 ounces of water and a small amount of food to lessen stomach discomfort You should take ZD6474 at about the same time every day Four 4 weeks is considered 1 treatment cycle If you miss a dose and are unable to take the missed dose on the same day you should take the next scheduled dose and the missed dose will not be made up The dose of study medication may be repeated if vomiting occurs within 30 minutes of taking the study medication
You will have routine blood tests about 2 teaspoons at Weeks 1 2 4 8 12 then every 4 weeks after that You will have an electrocardiogram ECG -- a test that measures the electrical activity of the heart at Weeks 1 2 4 8 12 then every 3 months after that Every 4 weeks your complete medical history will be recorded and you will have a physical exam including measurement of vital signs blood pressure heart rate temperature and breathing rate a performance status evaluation and weight You will also have a routine urine test and your study doctor will 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 you will have blood drawn about 1-2 teaspoons to check your blood clotting function every week You will be asked to bring your unused medication to each clinic visit
You may continue receiving ZD6474 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 andor 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 chest x-ray ECG 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
This is an investigational study ZD6474 is an investigational drug that has been approved by the FDA for research use only 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?:
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