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Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer (CUFOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490996
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):
University of Leicester

Brief 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.

Condition or disease Intervention/treatment Phase
Colonic Cancer Metastasis Drug: Oral complex C3 curcumin + chemotherapy Drug: Chemotherapy only Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Efficacy in terms of disease response and survival [ Time Frame: Up to 7 years ]
    Response rate will be measured using RECIST. Overall survival will be measured in months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological diagnosis of metastatic colorectal cancer
  • Measurable disease by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) (Appendix 1)
  • Adequate haematological, hepatic and renal function
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
  • Patients must have recovered from effects of any recent major surgery
  • Willing to use contraception if applicable
  • Informed consent
  • Life expectancy estimated to be more than 12 weeks

Exclusion Criteria:

  • Main exclusion criteria
  • Contraindications to FOLFOX chemotherapy: Peripheral neuropathy NCI CTC >1, Liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months.
  • Unwilling or unable to comply with the study protocol.
  • Patients who are pregnant or lactating or contemplating pregnancy. Patients or their partners who become pregnant during the study will be referred to the appropriate experts.
  • Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug study.
  • Previous cancer <5 years (other than colorectal, basal cell carcinoma, in-situ cervical cancer).
  • Major surgery within 4 weeks of starting the study
  • Co-existing active infection or serious concurrent medical condition
  • Significant cardiovascular disease
  • Bone metastases
  • Known brain or leptomeningeal metastases
  • Surgery or hospital admissions for symptomatic intra-abdominal adhesions
  • Active endoscopically proven peptic ulcer disease or colitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01490996

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United Kingdom
Dept Oncology, Leicester Royal Infirmary
Leicester, United Kingdom, LE1 2WW
Sponsors and Collaborators
University of Leicester
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Principal Investigator: Anne L Thomas, PhD FRCS University of Leicester/University Hospitals Leicester
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Leicester Identifier: NCT01490996    
Other Study ID Numbers: 0225
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: May 2017
Keywords provided by University of Leicester:
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Enzyme Inhibitors