A Phase II Study of Capecitabine and Oxaliplatin (XELOX) in Adenocarcinoma of the Small Bowel and Ampulla of Vater
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 M.D. 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 tumor(s)
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
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 M.D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response
Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
Robert A. Wolff, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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