NCT01490996

Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer

A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX) chemotherapy for up to 12 cycles(approximately 6 months) of treatment. Primary measurements focus on safety and tolerability. These will be recorded in real-time and report the number and severity of adverse events. Secondary measurements will include efficacy, (measured by response rate with RECIST and overall survival in months) supported by biomarker analysis.

Detailed description

Hypothesis Combination of oral curcumin with FOLFOX-based chemotherapy will be a safe and tolerated regimen for long-term administration to patients with colorectal metastases. Primary objectives 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. Secondary objectives 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.

Conditions

• Colonic Cancer
• Metastasis

Interventions

Type	Name	Description
DRUG	Oral complex C3 curcumin + chemotherapy	Daily oral capsule(s)
DRUG	Chemotherapy only	Standard care chemotherapy

Timeline

• Start date: 2012-02-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2011-12-13
• Last updated: 2020-01-31

Locations

1 site across 1 country: United Kingdom