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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.
 
ClinicalTrials.gov Identifier: NCT01490996
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Tracking Information
First Submitted Date  ICMJE December 7, 2011
First Posted Date  ICMJE December 13, 2011
Last Update Posted Date January 31, 2020
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • 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 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer
Official Title  ICMJE A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colonic Cancer
  • Metastasis
Intervention  ICMJE
  • Drug: Oral complex C3 curcumin + chemotherapy
    Daily oral capsule(s)
    Other Name: C3-complex curcumin (diferuloylmethane)
  • Drug: Chemotherapy only
    Standard care chemotherapy
    Other Name: FOLFOX (protocol includes changes to XELOX - capecitabine)
Study Arms  ICMJE
  • Active Comparator: Chemotherapy only
    Patients receiving up to 12 cycles of therapy. Standard care pathway management.
    Intervention: Drug: Chemotherapy only
  • Experimental: Chemotherapy plus curcumin
    Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.
    Intervention: Drug: Oral complex C3 curcumin + chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2011)
51
Actual Study Completion Date  ICMJE May 31, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01490996
Other Study ID Numbers  ICMJE 0225
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Leicester
Study Sponsor  ICMJE University of Leicester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne L Thomas, PhD FRCS University of Leicester/University Hospitals Leicester
PRS Account University of Leicester
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP