Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215930
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2005-09-15
Brief Title:
The MADe IT Clinical Trial Molecular Analyses Directed Individualized Therapy for Advanced Non-Small Cell Lung Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IVIIIB Malignant Pleural Effusion Non-Small-Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The standard treatment for non-small cell lung cancer stage IV or IIIB malignant pleural effusion is chemotherapy The decision to use a regimen is currently determined by toxicity or by physicians preference In this protocol the treatment regimen will be assigned based on the patients tumor molecular profile A tumor molecular profile analysis will allow the physician to define a specific molecular portrait that shows the genetic basis of the tumor This analysis results in a detailed report that will determine which chemotherapy will be assigned to the patient
Detailed Description:
Evaluation at study entry will include blood tests computerized tomography CT scans or other types of scans needed to measure other disease sites A biopsy of one tumor is required for tumor analysis If the patients cancer has spread to other locations that may be easier to obtain tissue from and be less invasive then the biopsy specimen may be collected from one of several possible locations that may exist within the patients body These possible sites include lung bone liver adrenal glands lymph nodes nodules under the skin or in cases of brain involvement requiring surgery brain tissue Sometimes fluids build up between the lining of the lung and the lung itself If this happened to the patient and their doctor tells them the fluid should be drained then this fluid may also be a source of cells we can use to analyze the patients cancer In very rare cases other sites might be identified
Chemotherapy will consist of the assigned two drugs Chemotherapy will be repeated every three or four weeks for at least two times Patients will then have a CT scan to measure their tumors response Response can be reduction of tumor size no change of tumor size or increased tumor size Doing CT Scans or other tests after every two cycles of chemotherapy will assess for response If we see a favorable response we will continue chemotherapy for a maximum of two times after the best response we can see in the patients tumor If the patients tumor grows larger then we discontinue the study and the patient will discuss other treatment options with their doctor
During treatment a blood specimen will be obtained to check the patients blood counts at the beginning and end of study and prior to administration of every dose of chemotherapy Approximately 3 teaspoonfuls 15 mls of blood will be drawn each time
Chemotherapy will consist of the assigned two drugs Chemotherapy will be repeated every three or four weeks for at least two times Patients will then have a CT scan to measure their tumors response Response can be reduction of tumor size no change of tumor size or increased tumor size Doing CT Scans or other tests after every two cycles of chemotherapy will assess for response If we see a favorable response we will continue chemotherapy for a maximum of two times after the best response we can see in the patients tumor If the patients tumor grows larger then we discontinue the study and the patient will discuss other treatment options with their doctor
During treatment a blood specimen will be obtained to check the patients blood counts at the beginning and end of study and prior to administration of every dose of chemotherapy Approximately 3 teaspoonfuls 15 mls of blood will be drawn each time
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