Trial of Curcumin in Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00094445|
Recruitment Status : Completed
First Posted : October 19, 2004
Results First Posted : August 28, 2020
Last Update Posted : August 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms Adenocarcinoma||Drug: Curcumin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Oral curcumin daily for eight weeks, starting dose 8 gm per day.
Starting dose 8 gm orally per day for 8 weeks. If patient experiences grade III toxicity, dose held and restarted with a 50% dose reduction after resolution of toxicity to </= Grade I. Patients with grade IV toxicity will discontinue treatments. Patients with </= grade I toxicity may have a 25% dose increase at each four-week period. Patients will continue on treatment until disease progresses, unless Grade III toxicity supervenes.
Other Name: diferuloyl methane
- Six-Month Participant Survival [ Time Frame: Baseline to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094445
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vivek Subbiah, MD||M.D. Anderson Cancer Center|