NCT01490996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

January 31, 2020

Status Verified

May 1, 2017

Enrollment Period

5.3 years

First QC Date

December 7, 2011

Last Update Submit

January 29, 2020

Conditions

Colonic CancerMetastasis

Keywords

CurcuminColorectal cancermetastasesFOLFOX

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (2)

  • Completion of (or withdrawal from) chemotherapy

    Up to 6 months

  • Efficacy in terms of disease response and survival

    Up to 7 years

Study Arms (2)

Chemotherapy only

ACTIVE COMPARATOR

Patients receiving up to 12 cycles of therapy. Standard care pathway management.

Drug: Chemotherapy only

Chemotherapy plus curcumin

EXPERIMENTAL

Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.

Drug: Oral complex C3 curcumin + chemotherapy

Interventions

Oral complex C3 curcumin + chemotherapyDRUG

Daily oral capsule(s)

Also known as: C3-complex curcumin (diferuloylmethane)
Chemotherapy plus curcumin
Chemotherapy onlyDRUG

Standard care chemotherapy

Also known as: FOLFOX (protocol includes changes to XELOX - capecitabine)
Chemotherapy only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Oncology, Leicester Royal Infirmary

Leicester, LE1 2WW, United Kingdom

Location

Related Publications (3)

  • Howells LM, Iwuji COO, Irving GRB, Barber S, Walter H, Sidat Z, Griffin-Teall N, Singh R, Foreman N, Patel SR, Morgan B, Steward WP, Gescher A, Thomas AL, Brown K. Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial. J Nutr. 2019 Jul 1;149(7):1133-1139. doi: 10.1093/jn/nxz029.

    PMID: 31132111DERIVED

  • James MI, Iwuji C, Irving G, Karmokar A, Higgins JA, Griffin-Teal N, Thomas A, Greaves P, Cai H, Patel SR, Morgan B, Dennison A, Metcalfe M, Garcea G, Lloyd DM, Berry DP, Steward WP, Howells LM, Brown K. Curcumin inhibits cancer stem cell phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy. Cancer Lett. 2015 Aug 10;364(2):135-41. doi: 10.1016/j.canlet.2015.05.005. Epub 2015 May 12.

    PMID: 25979230DERIVED

  • Irving GR, Iwuji CO, Morgan B, Berry DP, Steward WP, Thomas A, Brown K, Howells LM. Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomised control trial. Trials. 2015 Mar 24;16:110. doi: 10.1186/s13063-015-0641-1.

    PMID: 25872567DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasm MetastasisColorectal Neoplasms

Interventions

Drug TherapyCurcuminFolfox protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsRectal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsDiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Anne L Thomas, PhD FRCS

    University of Leicester/University Hospitals Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 13, 2011

Study Start

February 1, 2012

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

January 31, 2020

Record last verified: 2017-05

Locations

GB(1)