Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a
food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity
in the laboratory. During this study, you will receive much higher doses of curcumin than
can be obtained from the diet.
During the study, you will receive curcumin by mouth every day. You will be required to
take up to 16 pills per day each morning. Every 8-week period you take curcumin is
considered a "course" of treatment. The number of courses you receive depends on how you
are responding to treatment. You can continue treatment as long as the disease does not get
worse. If the disease gets worse or you experience any intolerable side effects, you will
be taken off the study and your doctor will discuss other treatment options with you.
You will be given a questionnaire to complete at the beginning of the study and once a week
while you are on therapy to help the medical staff understand how the different symptoms
from your disease are affecting you. This questionnaire, which should take about 5 minutes
to complete, can be done over the telephone or with the help of one of the study staff
during your visits.
At the end of each course of treatment (every 8 weeks), you will have a physical exam and
the tumor will be re-evaluated using CT scans and/or blood (about 2 tablespoons) tests.
This is an investigational study. Curcumin is a commercially available substance, which is
commonly used as a food additive. Up to 50 participants will take part in this study. All
will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Six-Month Participant Survival
Number of participants followed from baseline (date of randomization) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Vivek Subbiah, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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