Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer

Metastasis Clinical Trial

— CUFOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490996
• Other study ID #: 0225
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2012
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2017
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms
• Colorectal Neoplasms
• Metastasis
• Neoplasm Metastasis

Intervention

Drug:
• Oral complex C3 curcumin + chemotherapy
Daily oral capsule(s)
• Chemotherapy only
Standard care chemotherapy

Locations

Country	Name	City	State
United Kingdom	Dept Oncology, Leicester Royal Infirmary	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion of (or withdrawal from) chemotherapy	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.	Up to 6 months
Secondary	Efficacy in terms of disease response and survival	Response rate will be measured using RECIST. Overall survival will be measured in months.	Up to 7 years

External Links

•   University Of Leicester, Department of Cancer Studies and Molecular medicine