A Phase II Study of Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma, Including Carcinoma of the Gallbladder and Biliary Tract
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
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 tumor(s) 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
All tests before each new cycle of treatment and when treatment stops must be done at M. D.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Objective Response
Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Baseline with restaging every 3 cycles (cycle=21 days)
Melanie Thomas, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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