Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338988
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2006-06-16
Brief Title:
Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma Including Carcinoma of the Gallbladder and Biliary Tract
Status:
COMPLETED
Status Verified Date:
2012-07
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:
This is a Phase II trial of the combination of oxaliplatin Eloxatin and capecitabine Xeloda known as XELOX in participants with unresectable or recurrent cholangiocarcinoma including carcinoma of the gallbladder or biliary tract both intrahepatic and extrahepatic Participants may be either previously untreated or treated with chemotherapy Participants will accrue to two strata based on pre-treatment status separate response rates and statistical operating characteristics will be applied to each stratum
The primary objective is to determine the objective response rate complete plus partial of XELOX in this population
Secondary objectives include determining toxicity stable disease rates and median and overall survival of participants treated with this combination
The primary objective is to determine the objective response rate complete plus partial of XELOX in this population
Secondary objectives include determining toxicity stable disease rates and median and overall survival of participants treated with this combination
Detailed Description:
Oxaliplatin causes death of cancer cells and other actively dividing cells by interfering with DNA function Capecitabine causes death of cancer cells by interfering with certain molecules that are important in cell division
After the screening portion of the study if you are eligible to continue you will begin treatment with oxaliplatin and capecitabine Once treatment begins you will come to M D Anderson at least every three weeks 21 days for treatment Each 21-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy unless side effects are severe or the cancer grows very quickly
You will need to have a small tube central venous line inserted into a large vein under the skin of the chest or through a vein in the arm to receive oxaliplatin The central venous line will remain in place the entire time you are taking part in this study Oxaliplatin must be given at M D Anderson On Day 1 of each cycle you will receive oxaliplatin injected into a vein over 2 hours
You will take capecitabine tablets by mouth 2 times a day for the first 2 weeks Days 1-14 of each 3-week cycle No treatment will be given for the last 7 days of each cycle except if your first dose of capecitabine for a new cycle is taken in the evening your last dose will be taken in the morning of Day 15 You must take capecitabine within 30 minutes after breakfast and dinner The morning and evening doses should be about 12 hours apart You should take capecitabine with water and not with fruit juices At the first treatment visit and every 3 weeks you will receive enough capecitabine to last until the next visit At each visit you must return any capecitabine you have not used as well as all empty bottles
Before each new cycle of therapy you will have a complete physical exam and blood about 2 ½ teaspoons will be collected for routine tests You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced During the first cycle you will have a blood about 2 teaspoons sample collected each week for routine tests You will also have either CT scans or a MRI of the tumors every 9 weeks and at the end of the study Additional tests may be done during the study if your doctor feels it is necessary for your care
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 treatment on this study until the disease gets worse or you experience any intolerable side effects If this happens you will be taken off the study and your doctor will discuss other treatment options with you
When you stop taking part in the study you will have blood about 3 teaspoons collected for routine tests You will have a physical exam and either a CT scan or a MRI to check on the status of the disease You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing
All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson
This is an investigational study The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum However the drugs are not approved for gallbladder or biliary tract cancer Up to 50 participants will take part in this study All will be enrolled at M D Anderson
After the screening portion of the study if you are eligible to continue you will begin treatment with oxaliplatin and capecitabine Once treatment begins you will come to M D Anderson at least every three weeks 21 days for treatment Each 21-day period of treatment is called a cycle of therapy You will receive at least 3 cycles of therapy unless side effects are severe or the cancer grows very quickly
You will need to have a small tube central venous line inserted into a large vein under the skin of the chest or through a vein in the arm to receive oxaliplatin The central venous line will remain in place the entire time you are taking part in this study Oxaliplatin must be given at M D Anderson On Day 1 of each cycle you will receive oxaliplatin injected into a vein over 2 hours
You will take capecitabine tablets by mouth 2 times a day for the first 2 weeks Days 1-14 of each 3-week cycle No treatment will be given for the last 7 days of each cycle except if your first dose of capecitabine for a new cycle is taken in the evening your last dose will be taken in the morning of Day 15 You must take capecitabine within 30 minutes after breakfast and dinner The morning and evening doses should be about 12 hours apart You should take capecitabine with water and not with fruit juices At the first treatment visit and every 3 weeks you will receive enough capecitabine to last until the next visit At each visit you must return any capecitabine you have not used as well as all empty bottles
Before each new cycle of therapy you will have a complete physical exam and blood about 2 ½ teaspoons will be collected for routine tests You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced During the first cycle you will have a blood about 2 teaspoons sample collected each week for routine tests You will also have either CT scans or a MRI of the tumors every 9 weeks and at the end of the study Additional tests may be done during the study if your doctor feels it is necessary for your care
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 treatment on this study until the disease gets worse or you experience any intolerable side effects If this happens you will be taken off the study and your doctor will discuss other treatment options with you
When you stop taking part in the study you will have blood about 3 teaspoons collected for routine tests You will have a physical exam and either a CT scan or a MRI to check on the status of the disease You will be contacted by phone every three months for the rest of your life to check on the status of the disease and on any symptoms you may be experiencing
All tests before each new cycle of treatment and when treatment stops must be done at M D Anderson
This is an investigational study The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum However the drugs are not approved for gallbladder or biliary tract cancer Up to 50 participants will take part in this 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