The purpose of this study is to test the safety and find the response rate of combining the dietary supplement, curcumin, with the standard of care, FDA-approved chemotherapy drug 5-fluorouracil (5FU, Adracil) and see what effects (good and bad) that the combined treatments have on colon cancer.
Confirm clinical safety and identify clinical response rate of combination treatment with curcumin and 5FU in chemorefractory CRC patients. To determine whether curcumin administration induces systemic alterations in inflammatory and epigenetic biomarkers in patients with chemoresistant metastatic colorectal cancer (CRC). To correlate altered biomarker findings with clinical response according to RECIST V1.1 and survival criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Curcumin is supplied as soft-gel capsule. It is a micronized rhizome extract containing phospholipids and 500mg of pure curcuminoids (95% curcumin, 5% desmethoxycurcumin) suspended in turmeric essential oil.
Fluorouracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Fluorouracil is classified as an antimetabolite.
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Determine the safety using curcumin in patients with metastatic colon cancer; where toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Events will be recorded from the time of informed consent signature through the 30 days following the last study treatment.
Time frame: 12 weeks
Overall Response
Recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the finding of target and non-target disease and will also take into consideration the appearance of new lesions.
Time frame: 12 months
Evidence of altered biomarker status (circulating DNA methylation status, miRNA profile) at 8 weeks post-treatment according to RECIST version 1.1 and survival criteria.
Blood will be collected at baseline, after completing one cycle of curcumin treatment (2 weeks), and after completing three 2 week-cycles of 5FU (6 weeks) for inflammatory and epigenetic chemoresponsive biomarker profiling.
Time frame: Baseline, Week 2, Week 8
Duration of response
Time frame: 12 months
Duration of progression free survival
Time frame: 12 months
Duration of overall survival
Time frame: 12 months
Duration of Quality of Life
All subjects will complete the quality of life survey at Baseline, 5FU treatment visits and follow-up visits.
Time frame: Baseline, 12 months
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