Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354978
Status:
COMPLETED
Last Update Posted:
2011-10-21
First Post:
2006-07-18
Brief Title:
Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Irinotecan Leucovorin 5-Fluorouracil FOLFIRI Plus Bevacizumab as First-Line Treatment for Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2011-09
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:
Objectives
1 To estimate progression-free survival PFS at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI folinic acid leucovorin or LV 5-Fluorouracil 5-FU irinotecan plus bevacizumab as first line treatment
2 To determine the objective response rate and the duration of objective response in this population
3 To assess overall survival OS in this population
4 To measure the effect of treatment on intratumoral blood volume and microvascular permeability by dynamic contrast-enhanced magnetic resonance imaging DCE-MRI in consenting patients in whom it is technically feasible
5 To correlate plasma proteomics with response
6 To assess the safety of this regimen
1 To estimate progression-free survival PFS at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI folinic acid leucovorin or LV 5-Fluorouracil 5-FU irinotecan plus bevacizumab as first line treatment
2 To determine the objective response rate and the duration of objective response in this population
3 To assess overall survival OS in this population
4 To measure the effect of treatment on intratumoral blood volume and microvascular permeability by dynamic contrast-enhanced magnetic resonance imaging DCE-MRI in consenting patients in whom it is technically feasible
5 To correlate plasma proteomics with response
6 To assess the safety of this regimen
Detailed Description:
Colorectal cancer growth may be affected by a protein in the body called vascular endothelial growth factor VEGF A drug that blocks VEGF may be an effective treatment for colorectal cancer Bevacizumab is designed to block VEGF Bevacizumab will be added to 5-Fluorouracil 5-FU leucovorin LV and irinotecan a drug combination routinely used in the treatment of advanced colorectal cancer
Before you can start treatment on the study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past You will have a complete physical exam and your heart rate temperature breathing rate blood pressure height and weight will be measured You will be asked about your ability to perform every day activities You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart You will have a chest x-ray and scans either computed tomography CT or magnetic resonance imaging MRI of your abdomen and pelvis to evaluate the cancer Scans of other parts of your body also may be taken if your doctor thinks they are needed to evaluate your cancer Blood about 3 tablespoons and urine samples will be collected for routine tests including complete blood count carcinoembryonic antigen CEA level a marker for your cancer and chemistry profile Women who are able to have children must have a negative blood or urine pregnancy test
If the screening evaluations show you are eligible to take part in the study you may begin treatment Study treatment is repeated every 2 weeks 14 days Each 14-day period of treatment is called a cycle of therapy You must receive study treatment at M D Anderson
All study drugs will be given through a needle into a vein For your first treatment you will receive bevacizumab alone first The first dose of bevacizumab will be given over about 90 minutes If you do not have a reaction such as feverchills the next dose will be given over about 60 minutes and if again no reaction occurs each dose after that will be given over about 30 minutes If you experience a reaction to the bevacizumab infusion you may be given acetaminophen such as Tylenol by mouth andor an antihistamine by vein over 30 minutes before each dose to help decrease the risk of further reactions
Fourteen 14 days later and for all future cycles you will receive bevacizumab LV and irinotecan given on Day 1 of each cycle 5-FU is given over 46 hours over Days 1-3
Bevacizumab will be given as described above When the bevacizumab infusion ends you will receive LV and irinotecan starting at the same time You will receive irinotecan over 90 minutes and LV over 2 hours When the LV infusion ends 5-FU will be given over 2 to 4 minutes This is followed by more 5-FU given over 46 hours using a small portable pump about the size of a standard paperback book
Before each new cycle of study treatment you will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor You will have a complete physical exam including measurements of blood pressure pulse temperature and weight You will be asked about your ability to perform every day tasks About 3 tablespoons of blood will be taken for routine laboratory tests These tests include a complete blood count and chemistry profile A urine sample will be taken before every other cycle of treatment During the first cycle of treatment on Day 8 you will have a sample of blood about 3 teaspoons drawn This test may be done at a lab close to your home
You will also have either CT scans or MRI of the tumors every 8 weeks and at the end of the study treatment About 1 tablespoon of blood will be taken to check your CEA level at the same time scans are done Additional tests may be done during the study if your doctor feels it is necessary for your care Except for the weekly blood test which may be done at a lab close to home all testing and evaluations must be done at M D Anderson
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of the treatment You may continue to receive study treatment unless the disease gets worse you decide not to take part any longer or your doctor decides it is in your best interest to stop treatment
When you stop study treatment you will be asked to have some tests and evaluations done at an end of study visit Urine and about 3 tablespoons of blood will be taken for routine laboratory tests including complete blood count CEA level and chemistry profile You will also have a physical exam CT scan or MRI scan of your abdomen and pelvis will also be done to check the size and location of your disease
Once you stop receiving study treatment the study doctor or nurse will continue to check how you are doing either in the clinic or by telephone if you stop coming to M D Anderson every 3 months for the rest of your life
This is an investigational study The drugs used in this study are approved by the FDA for treatment of advanced colorectal cancer Up to 43 patients will take part in this multicenter study About 38 will be enrolled at M D Anderson
Before you can start treatment on the study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past You will have a complete physical exam and your heart rate temperature breathing rate blood pressure height and weight will be measured You will be asked about your ability to perform every day activities You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart You will have a chest x-ray and scans either computed tomography CT or magnetic resonance imaging MRI of your abdomen and pelvis to evaluate the cancer Scans of other parts of your body also may be taken if your doctor thinks they are needed to evaluate your cancer Blood about 3 tablespoons and urine samples will be collected for routine tests including complete blood count carcinoembryonic antigen CEA level a marker for your cancer and chemistry profile Women who are able to have children must have a negative blood or urine pregnancy test
If the screening evaluations show you are eligible to take part in the study you may begin treatment Study treatment is repeated every 2 weeks 14 days Each 14-day period of treatment is called a cycle of therapy You must receive study treatment at M D Anderson
All study drugs will be given through a needle into a vein For your first treatment you will receive bevacizumab alone first The first dose of bevacizumab will be given over about 90 minutes If you do not have a reaction such as feverchills the next dose will be given over about 60 minutes and if again no reaction occurs each dose after that will be given over about 30 minutes If you experience a reaction to the bevacizumab infusion you may be given acetaminophen such as Tylenol by mouth andor an antihistamine by vein over 30 minutes before each dose to help decrease the risk of further reactions
Fourteen 14 days later and for all future cycles you will receive bevacizumab LV and irinotecan given on Day 1 of each cycle 5-FU is given over 46 hours over Days 1-3
Bevacizumab will be given as described above When the bevacizumab infusion ends you will receive LV and irinotecan starting at the same time You will receive irinotecan over 90 minutes and LV over 2 hours When the LV infusion ends 5-FU will be given over 2 to 4 minutes This is followed by more 5-FU given over 46 hours using a small portable pump about the size of a standard paperback book
Before each new cycle of study treatment you will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor You will have a complete physical exam including measurements of blood pressure pulse temperature and weight You will be asked about your ability to perform every day tasks About 3 tablespoons of blood will be taken for routine laboratory tests These tests include a complete blood count and chemistry profile A urine sample will be taken before every other cycle of treatment During the first cycle of treatment on Day 8 you will have a sample of blood about 3 teaspoons drawn This test may be done at a lab close to your home
You will also have either CT scans or MRI of the tumors every 8 weeks and at the end of the study treatment About 1 tablespoon of blood will be taken to check your CEA level at the same time scans are done Additional tests may be done during the study if your doctor feels it is necessary for your care Except for the weekly blood test which may be done at a lab close to home all testing and evaluations must be done at M D Anderson
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of the treatment You may continue to receive study treatment unless the disease gets worse you decide not to take part any longer or your doctor decides it is in your best interest to stop treatment
When you stop study treatment you will be asked to have some tests and evaluations done at an end of study visit Urine and about 3 tablespoons of blood will be taken for routine laboratory tests including complete blood count CEA level and chemistry profile You will also have a physical exam CT scan or MRI scan of your abdomen and pelvis will also be done to check the size and location of your disease
Once you stop receiving study treatment the study doctor or nurse will continue to check how you are doing either in the clinic or by telephone if you stop coming to M D Anderson every 3 months for the rest of your life
This is an investigational study The drugs used in this study are approved by the FDA for treatment of advanced colorectal cancer Up to 43 patients will take part in this multicenter study About 38 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