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

Phase 1/Phase 2
18 Years
Not Enrolling
Colonic Cancer, Metastasis

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Trial Information

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

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

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

- Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Completion of dose escalation over 2 cycles of therapy

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

William P Steward, PhD FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Leicester/University Hospitals Leicester


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2012

Completion Date:

January 2019

Related Keywords:

  • Colonic Cancer
  • Metastasis
  • Curcumin
  • Colorectal cancer
  • metastases
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis