A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.
Hypothesis Combination of oral curcumin with FOLFOX-based chemotherapy will be a safe and
tolerated regimen for long-term administration to patients with colorectal liver metastases.
To establish a tolerated dose of daily oral curcumin to be taken long-term with FOLFOX-based
chemotherapy in patients with metastatic colorectal cancer will be conducted to assess:
1. Safety, tolerability and feasibility of administering oral curcumin at increasing doses
escalating to 4 capsules (≈2 g C3-complex) during FOLFOX-based chemotherapy and continued
for the duration of the chemotherapy course.
1. To observe any changes to the neuropathic side-effects of chemotherapy.
2. To observe potential for efficacy in terms of disease response and survival.
3. To identify putative biomarkers in plasma.
This is a phase I/IIa study:
Phase I will be a traditional escalation response design study (or 3+3+3) to firstly assess
the safety of this combination and identify a maximum tolerated dose up to 4 g per day.
Phase IIa will be a randomised control study comparing curcumin and FOLFOX with FOLFOX
alone, recruited at a 2:1 ratio respectively.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Completion of dose escalation over 2 cycles of therapy
Patients will start curcumin a week prior to chemotherapy. Upon completion of two cycles of therapy without dose-limiting toxicity in 3 consecutive patients, the dose will be escalated for the next 3 patients. Real-time adverse event reporting will be undertaken to record number and severity of events.
William P Steward, PhD FRCS
University of Leicester/University Hospitals Leicester
United Kingdom: Medicines and Healthcare Products Regulatory Agency