A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.
18 Years
N/A
Both
Colonic Cancer, Metastasis
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
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
Type of Study:
Interventional
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:
Yes
Principal Investigator
William P Steward, PhD FRCS
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Leicester/University Hospitals Leicester
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
UNOLE0225
NCT ID:
NCT01490996
Start Date:
January 2012
Completion Date:
January 2019
Related Keywords:
- Colonic Cancer
- Metastasis
- Curcumin
- Colorectal cancer
- metastases
- FOLFOX
- Colonic Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
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