Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354887
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2006-07-18
Brief Title:
Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Capecitabine and Oxaliplatin XELOX in Adenocarcinoma of the Small Bowel and Ampulla of Vater
Status:
COMPLETED
Status Verified Date:
2012-10
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
1 To determine the objective response rate complete plus partial to the combination of capecitabine Xeloda and oxaliplatin Eloxatin XELOX in patients with adenocarcinoma of the small bowel and ampulla of Vater
Secondary objectives include determining the toxicity time-to-treatment failure and overall survival rates in patients treated with this combination
1 To determine the objective response rate complete plus partial to the combination of capecitabine Xeloda and oxaliplatin Eloxatin XELOX in patients with adenocarcinoma of the small bowel and ampulla of Vater
Secondary objectives include determining the toxicity time-to-treatment failure and overall survival rates in patients treated with this combination
Detailed Description:
Oxaliplatin is a chemotherapy drug designed to destroy cancer cells by interfering with DNA function which is necessary for growth of new cells
Capecitabine is a chemotherapy drug designed to destroy cancer cells by interfering with cell division which is important to the growth of cancer
You will receive 14 days of treatment followed by 7 days without treatment 21 days in all otherwise known as a cycle of therapy On Day 1 of each cycle you will receive oxaliplatin injected into a vein over a period of 2 hours For this injection you will need to have a small tube inserted into a vein under the skin of the chest central venous line to receive oxaliplatin Oxaliplatin must be given at MD Anderson
You will take capecitabine tablets twice a day for the first two weeks Days 1-14 of each 3-week cycle No treatment will be given for the next 7 days You must take capecitabine within 30 minutes after breakfast and dinner with morning and evening doses about 12 hours apart You should take capecitabine by mouth with water and not 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
During Cycle 1 routine blood tests about 2 teaspoons of blood will be done once a week 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 by the study doctor about all medications you have taken since starting the study drugs and any health problems that you may have experienced Also you will have an x-ray or computed tomography CT scan of the chest and either CT scans or magnetic resonance imaging MRIs of the tumors every 3 cycles 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
This study will require you to receive at least 3 cycles of treatment However if you experience severe side effects or your disease becomes worse 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 an 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 your state of health and ask you about further symptoms you may be experiencing
This is an investigational study The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum The drugs are not approved for small bowel or ampulla of Vater cancer Their use together in this study is investigational Up to 30 people will take part in this study All will be enrolled at MD Anderson
Capecitabine is a chemotherapy drug designed to destroy cancer cells by interfering with cell division which is important to the growth of cancer
You will receive 14 days of treatment followed by 7 days without treatment 21 days in all otherwise known as a cycle of therapy On Day 1 of each cycle you will receive oxaliplatin injected into a vein over a period of 2 hours For this injection you will need to have a small tube inserted into a vein under the skin of the chest central venous line to receive oxaliplatin Oxaliplatin must be given at MD Anderson
You will take capecitabine tablets twice a day for the first two weeks Days 1-14 of each 3-week cycle No treatment will be given for the next 7 days You must take capecitabine within 30 minutes after breakfast and dinner with morning and evening doses about 12 hours apart You should take capecitabine by mouth with water and not 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
During Cycle 1 routine blood tests about 2 teaspoons of blood will be done once a week 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 by the study doctor about all medications you have taken since starting the study drugs and any health problems that you may have experienced Also you will have an x-ray or computed tomography CT scan of the chest and either CT scans or magnetic resonance imaging MRIs of the tumors every 3 cycles 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
This study will require you to receive at least 3 cycles of treatment However if you experience severe side effects or your disease becomes worse 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 an 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 your state of health and ask you about further symptoms you may be experiencing
This is an investigational study The drugs oxaliplatin and capecitabine are FDA approved for treatment of advanced cancer of the colon or rectum The drugs are not approved for small bowel or ampulla of Vater cancer Their use together in this study is investigational Up to 30 people will take part in this study All will be enrolled at MD 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