Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
The Study Drugs:
Oxaliplatin is designed to block new cancer cells from growing.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.
Capecitabine is designed to interfere with the growth of cancer cells.
Study Drug Administration:
If you are found eligible to take part in this study, you will receive the study drugs in
21-day "study cycles."
To receive oxaliplatin, you will have a central venous catheter (CVC) placed. A CVC is a
sterile, flexible tube that will be placed into a large vein while you are under local
anesthesia. Your doctor will explain this procedure to you in more detail, and you will be
required to sign a separate consent form for this procedure.
You will receive oxaliplatin through the CVC over 2 hours on Day 1 of each cycle, before
bevacizumab.
You will receive bevacizumab through a needle in your vein on Day 1 of each cycle. The
first time you receive bevacizumab, it will be given over 90 minutes. If you do not have
infusion-related side effects from bevacizumab, all other bevacizumab doses will be given
over 30-60 minutes.
You will take capecitabine by mouth 2 times each day on Days 1-14 of each cycle.
Capecitabine tablets should be taken 12 hours apart, within 30 minutes after eating a meal
with a cup (8 ounces) of water. If you miss a dose, do not try to make up the dose by
doubling your next dose.
Study Visits:
There will be no study visits for Cycle 1. Up to 3 days before or on Day 1 of all Cycles
after Cycle 1, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight, nerve function,
and blood pressure.
- You will be asked about any drugs you may be taking.
- You will be asked about any symptoms or side effects you may be having.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
At the end of Cycles 3, 6, 9, and so on:
- You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status
of the disease.
- Urine will be collected to check your kidney function. Based on the results of the
urine test, you may be asked to collect your urine over 24 hours to further test your
kidney function. You will be given a container to collect the urine.
Length of Treatment:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse, if
you have intolerable side effects, or if the study is stopped.
End-of-Treatment Visit:
Within 10 days after you stop taking the study drugs, you will have an end-of-treatment
visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight, nerve function,
and blood pressure.
- You will be asked about any drugs you may be taking.
- You will be asked about any symptoms or side effects you may be having.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have a CT or MRI scan of your chest, abdomen, and pelvis to check the status
of the disease.
Follow-Up:
The study staff will ask about any symptoms or side effects you may be having during the 30
days after your last dose of the study drugs. The study staff may contact you by phone or
at the time of a routine clinic visit. If the study staff contacts you by phone, the phone
call should last about 15-30 minutes.
The study staff will also review your medical records and/or contact you to check the status
of the disease every 3 months after you stop receiving the study drugs. If you are contacted
by phone, each phone call should take about 5 minutes.
If you leave the study for any reason other than the disease getting worse, you will have a
CT or MRI scan of your chest, abdomen, and pelvis to check the status of the disease every
12 weeks unless you start receiving other treatment or the disease gets worse.
Stopping Study Participation:
You can decide to leave the study at any time. It is important to tell the study doctor if
you are thinking about stopping so any side effects/risks from the treatment can be checked
by your doctor. Another reason to tell your doctor that you are thinking about stopping is
to discuss what follow-up care and testing could be helpful for you.
This is an investigational study. Bevacizumab, oxaliplatin, and capecitabine are each FDA
approved and commercially available for the treatment of some types of cancer, including
colon and rectal cancer. They are not FDA approved for the treatment of small bowel or
ampulla of Vater cancer. The use of the combination of oxaliplatin, capecitabine, and
bevacizumab in patients with cancer of the small bowel or ampulla of Vater is
investigational.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Progression-Free Survival (PFS)
6 months
Yes
Michael Overman, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0626
NCT01208103
May 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |