Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer (CUFOX)
|ClinicalTrials.gov Identifier: NCT01490996|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2011
Last Update Posted : May 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Colonic Cancer Metastasis||Drug: Oral complex C3 curcumin + chemotherapy Drug: Chemotherapy only||Phase 1 Phase 2|
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.
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.
- To observe any changes to the neuropathic side-effects of chemotherapy.
- To observe potential for efficacy in terms of disease response and survival.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Active Comparator: Chemotherapy only
Patients receiving up to 12 cycles of therapy. Standard care pathway management.
Drug: Chemotherapy only
Standard care chemotherapy
Other Name: FOLFOX (protocol includes changes to XELOX - capecitabine)
Experimental: Chemotherapy plus curcumin
Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.
Drug: Oral complex C3 curcumin + chemotherapy
Daily oral capsule(s)
Other Name: C3-complex curcumin (diferuloylmethane)
- Completion of dose escalation over 2 cycles of therapy [ Time Frame: 1 year ]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.
- Completion of (or withdrawal from) chemotherapy [ Time Frame: Up to 6 months ]Compliance in the study will be measured in months/cycles of therapy tolerated. Reasons for withdrawal or cessation will be documented which will include mortality, adverse events and patient reported outcomes of tolerance to the protocol regimen.
- Efficacy [ Time Frame: Up to 7 years ]Response rate will be measured using RECIST. Overall survival will be measured in months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490996
|Dept Oncology, Leicester Royal Infirmary|
|Leicester, United Kingdom, LE1 2WW|
|Principal Investigator:||Anne L Thomas, PhD FRCS||University of Leicester/University Hospitals Leicester|