Overview

This trial is active, not recruiting.

Conditions colonic cancer, metastasis
Treatments oral complex c3 curcumin + chemotherapy, chemotherapy only
Phase phase 1/phase 2
Sponsor University of Leicester
Start date February 2012
End date February 2019
Trial size 51 participants
Trial identifier NCT01490996, UNOLE0225

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients receiving up to 12 cycles of therapy. Standard care pathway management.
chemotherapy only FOLFOX (protocol includes changes to XELOX - capecitabine)
Standard care chemotherapy
(Experimental)
Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.
oral complex c3 curcumin + chemotherapy C3-complex curcumin (diferuloylmethane)
Daily oral capsule(s)

Primary Outcomes

Measure
Completion of dose escalation over 2 cycles of therapy
time frame: 1 year

Secondary Outcomes

Measure
Completion of (or withdrawal from) chemotherapy
time frame: Up to 6 months
Efficacy
time frame: Up to 7 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.
Principal investigator Anne L Thomas, PhD FRCS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Leicester.