Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161278
Status:
TERMINATED
Last Update Posted:
2008-07-30
First Post:
2005-09-08
Brief Title:
Pilot Study for the Determination of Tumor Response to Chemotherapy in Advanced NSCLC Through Gene Expression Profiling
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Pilot Study for the Determination of Tumor Response to Chemotherapy in Advanced Non-Small Cell Lung Cancer Through Gene Expression Profiling
Status:
TERMINATED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment has ended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who are at least 18 years of age and have a type of cancer known as advanced non-small cell lung cancer may be eligible for this study if they meet all of the inclusionexclusion criteria
Background The standard treatment for patients with advanced non-small cell cancer is chemotherapy The two drug combination carboplatin Paraplatin and paclitaxel Taxol is commonly used as the first treatment Unfortunately standard treatment with chemotherapy only shrinks the cancer in about 30 of patients that receive it There is no way to predict who will or wont benefit from this treatment The researchers at the University of Michigan would like to determine if the genes of the lung cancers in patients enrolled in this study will help predict whether or not the tumors shrink when exposed to standard chemotherapy The goal is to find a set of lung cancer genes that will predict successful treatment with carboplatin and paclitaxel in patients with non-small cell lung cancer
The actual treatment carboplatin and paclitaxel involved in this study is not experimental The experimental aspect of this study is the identification of predictors of response to treatment To do this it would require a sample of your cancer If your initial surgery or biopsy was done at the University of Michigan we may already have an adequate sample of your cancer that could be used for this research In that case we are asking for your permission to use this sample for this study However if you meet all eligibility criteria and agree to participate in this research study and an adequate sample is not available you will need to undergo another biopsy procedure for us to obtain a sample of your cancer Obtaining a tumor sample is the most crucial part of this research study
Background The standard treatment for patients with advanced non-small cell cancer is chemotherapy The two drug combination carboplatin Paraplatin and paclitaxel Taxol is commonly used as the first treatment Unfortunately standard treatment with chemotherapy only shrinks the cancer in about 30 of patients that receive it There is no way to predict who will or wont benefit from this treatment The researchers at the University of Michigan would like to determine if the genes of the lung cancers in patients enrolled in this study will help predict whether or not the tumors shrink when exposed to standard chemotherapy The goal is to find a set of lung cancer genes that will predict successful treatment with carboplatin and paclitaxel in patients with non-small cell lung cancer
The actual treatment carboplatin and paclitaxel involved in this study is not experimental The experimental aspect of this study is the identification of predictors of response to treatment To do this it would require a sample of your cancer If your initial surgery or biopsy was done at the University of Michigan we may already have an adequate sample of your cancer that could be used for this research In that case we are asking for your permission to use this sample for this study However if you meet all eligibility criteria and agree to participate in this research study and an adequate sample is not available you will need to undergo another biopsy procedure for us to obtain a sample of your cancer Obtaining a tumor sample is the most crucial part of this research study
Detailed Description:
Prior to the start of treatment subjects will have a complete history and physical examination and blood tests to evaluate their overall health The doctor will also obtain a tissue sample biopsy of the tumor taken from the subjects body to evaluate the genes that are expressed within the tumor Doctors from the University of Michigan will do an analysis on the tissue to understand the genetic nature of each subjects tumor If the subjects initial surgery or biopsy was done at the University of Michigan we may already have an adequate sample of their cancer that could be used for this research In that case we would be asking for their permission to use this sample for this study However if subjects agree to participate in this research study and an adequate sample is not available they will need to undergo another biopsy procedure for us to obtain a sample of your cancer
A biopsy of a subjects tumor can be obtained from various sites of their body using a number of different methods We will select a location that will be the easiest and safest place to biopsy and that will provide an adequate sample of tumor tissue Biopsy sites will generally be superficial for example lymph nodes skin nodules chest wall tumors The usual method of biopsy will be the placement of a large needle into the tumor to obtain a core of tissue In some situations we may ask to have a superficial tumor removed in whole or part by a minor surgical procedure If neither of these methods can be done safely we may place a thin needle into the tumor and aspirate suck out some tumor cells for study All procedures will be done with local anesthesia that is injection of medication directly into the biopsy site to numb the area prior to biopsy and appropriate care to avoid excessive bleeding or subsequent infection The doctors will explain the specific biopsy location and technique that fits each subjects situation to them in detail prior to the procedure They can decide not to go through with the biopsy and withdraw from this research trial at any time
Subjects will then be given carboplatin and paclitaxel intravenously through a vein over 2 hours This will be repeated every three weeks for a total of six to eighteen weeks Three weeks is considered a cycle and each subject will receive 1 to 6 cycles depending on how their tumor responds and how the treatment is tolerated Treatment will be stopped if the tumor gets worse or if a subject develops unacceptable side-effects
Physical examinations blood tests and x-rays andor scans will be done routinely during the therapy so the doctor can check the subjects body and your tumor response to treatment Blood samples consisting of 2-3 teaspoonfuls 10-15 cc each will be obtained twice every three weeks during the study to evaluate the effect of the treatment on their blood counts blood electrolytes liver and kidney function
A biopsy of a subjects tumor can be obtained from various sites of their body using a number of different methods We will select a location that will be the easiest and safest place to biopsy and that will provide an adequate sample of tumor tissue Biopsy sites will generally be superficial for example lymph nodes skin nodules chest wall tumors The usual method of biopsy will be the placement of a large needle into the tumor to obtain a core of tissue In some situations we may ask to have a superficial tumor removed in whole or part by a minor surgical procedure If neither of these methods can be done safely we may place a thin needle into the tumor and aspirate suck out some tumor cells for study All procedures will be done with local anesthesia that is injection of medication directly into the biopsy site to numb the area prior to biopsy and appropriate care to avoid excessive bleeding or subsequent infection The doctors will explain the specific biopsy location and technique that fits each subjects situation to them in detail prior to the procedure They can decide not to go through with the biopsy and withdraw from this research trial at any time
Subjects will then be given carboplatin and paclitaxel intravenously through a vein over 2 hours This will be repeated every three weeks for a total of six to eighteen weeks Three weeks is considered a cycle and each subject will receive 1 to 6 cycles depending on how their tumor responds and how the treatment is tolerated Treatment will be stopped if the tumor gets worse or if a subject develops unacceptable side-effects
Physical examinations blood tests and x-rays andor scans will be done routinely during the therapy so the doctor can check the subjects body and your tumor response to treatment Blood samples consisting of 2-3 teaspoonfuls 10-15 cc each will be obtained twice every three weeks during the study to evaluate the effect of the treatment on their blood counts blood electrolytes liver and kidney function
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