|Phase I||Biomarker/Laboratory analysis, Prevention||Active||18 and over||Other||CDR0000648267|
LRI-UL-CURCUMIN, EUDRACT-2007-001971-13, EU-20961, UL-CURCUMIN, NCT00973869
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of curcumin may prevent or treat colorectal cancer.
PURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.
Further Study Information
- To determine levels of curcumin and its metabolites in normal colorectal tissue in patients undergoing colorectal endoscopy or colorectal cancer surgery following a 14-day course of curcumin.
- To assess the practicality, acceptability, and safety of administering 5 capsules of curcumin daily for 14 days.
- To check the presence of curcumin and its metabolites in peripheral blood and urine.
OUTLINE: Patients receive oral curcumin once daily for 14-28 days. Patients then undergo colorectal endoscopy or resection.
Normal colorectal tissue samples are collected via biopsy for curcumin assay after the last dose of curcumin. Patients also undergo blood and urine sample collection at baseline and after the last dose of curcumin for pharmacokinetic analysis by high performance liquid chromatography.
After completion of study treatment, patients are followed up at 14 days.
- Meets 1 of the following criteria:
- Has a positive fecal occult blood test found during a pilot colorectal cancer screening program
- Awaiting diagnostic or surveillance colonoscopy
- Diagnosis of colorectal cancer
- Able to return for follow-up tests
- Fertile patients must use effective contraception
- No discrete gastric or duodenal ulcer > 5 mm in the past year
- Patients with a history of Helicobacter pylori-related peptic ulcer disease are eligible after successfully completing antibiotic treatment for Helicobacter pylori
- No significant medical or psychiatric problem, including significant renal, hepatic, or hematological dysfunction, that would make the patient a poor candidate for this study
PRIOR CONCURRENT THERAPY:
- More than 3 months since prior investigational agents
- No prior pelvic radiotherapy
- No other concurrent investigational agents
Trial Lead Organizations/Sponsors
University Hospitals of Leicester NHS Trust
|William P. Steward||Principal Investigator|
|St. Mark's Hospital|
|Contact Person||Ph: 44-20-8235-4225|
|Leicester Royal Infirmary|
|William P. Steward, MD, PhD||Ph: 44-116-258-7597|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00973869
ClinicalTrials.gov processed this data on October 17, 2013
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