Translating curcumin into clinical practice for treatment of metastatic colorectal cancer: the CUFOX trial. Doctoral (PhD) Thesis. University of Leicester, UK. Degree Awarded date: April 26, 2017.Iwuji, COO
Colorectal cancer is also called bowel cancer, colon cancer, or rectal cancer, is any cancerous growth that affects the colon and the rectum. Curcumin is a low molecular weight polyphenol derived from the spice turmeric that inhibits carcinogenesis in vitro and in vivo via multi-targeted mechanisms. A clinical study was established investigating the safety and feasibility of administering curcumin with standard oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer.
To investigate the safety and feasibility of administering curcumin with standard oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer.
The study was conducted in two phases
- Phase I was a dose-escalation phase using the traditional escalation rule (3+3+3) design to establish the maximum target dose of curcumin
- Phase II was an open-labeled, two-armed, randomized controlled feasibility trial. Patients received standard oxaliplatin and 5-FU chemotherapy with or without the maximum target dose of curcumin established in Phase I
- Biomarker studies were conducted involving measurement of miR-122, curcumin/curcuminoids and DNA platination in patient plasma samples, and proteomic analysis of treated explant media from patient-derived colorectal liver metastasis
- Phase I dose escalation was successfully completed with thirteen patients receiving curcumin plus standard oxaliplatin-based chemotherapy up to the target dose of 2 grams daily with no significant issues identified with toxicity or feasibility
- Eighteen patients had been recruited into Phase IIa at the time of this report with no notable safety concerns. Changes in miRNA and curcumin/curcuminoid levels were successfully measured in patient plasma samples
- Explant culture analysis showed proteins involved in apoptosis, angiogenesis and inflammation/immune response were selectively upregulated following treatment with CUFOX
The addition of curcumin to standard FOLFOX chemotherapy up to a dose of 2 grams daily has shown good tolerability, feasibility and no safety concerns across Phase I and Phase IIa of this study.