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| Sponsored by: |
M.D. Anderson Cancer Center |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00094445 |
Purpose
The purpose of this trial is to evaluate the efficacy of Curcumin (an ingredient in the spice, tumeric) taken orally in patients with advanced pancreatic cancer (e.g. the cancer cannot be surgically removed, has come back, and/or has spread beyond the pancreas). We will also evaluate the side-effects of Curcumin in this patient population and measure the amounts of Curcumin in the blood and/or tissue (optional).
| Condition | Intervention | Phase |
|
Pancreatic Neoplasms Adenocarcinoma |
Drug: Curcumin (diferuloyl methane) |
Phase II |
| MedlinePlus related topics: | Cancer Pancreatic Cancer |
| ChemIDplus related topics: | Pancrelipase Ultrase Curcumin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Trial of Curcumin in Patients With Advanced Pancreatic Cancer |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2004 |
| Study Completion Date: | March 2007 |
Curcumin (diferuloyl methane) is the active compound in the dietary ingredient tumeric. Curcumin has potent irreversible antiproliferative effects against a variety of cancer cell lines in vitro and chemopreventive effects in murine carcinoma models. Furthermore, this compound demonstrates little in the way of toxicity in animals as well as in preliminary Phase I trials in humans. Taken together with the dismal therapeutic options available for pancreatic cancer patients, these results suggest that curcumin warrants investigation. We, therefore, propose to perform an exploratory clinical/translational trial of curcumin in patients with unresectable or metastatic pancreatic cancer. This trial will provide essential data on in vivo biological and clinical effects and pharmacology of curcumin in patients with pancreatic cancer, and should serve as a foundation for additional studies which incorporate curcumin in the adjuvant setting and/or combine it with chemotherapeutic/biologic agents in patients with pancreatic as well as other cancers.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |||||
| M.D. Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| M.D. Anderson Cancer Center |
| Principal Investigator: | Razelle Kurzrock, MD | U.T. M.D. Anderson Cancer Center |
More Information
Home page for M.D. Anderson Cancer Center 
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| Study ID Numbers: | ID03-0009, 1R21CA104337 |
| First Received: | October 18, 2004 |
| Last Updated: | March 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00094445 |
| Health Authority: | United States: Food and Drug Administration |
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