Status:
COMPLETED
Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer
Lead Sponsor:
University of Leicester
Conditions:
Colonic Cancer
Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01490996
Start Date
February 1 2012
End Date
May 31 2017
Last Update
January 31 2020
Active Locations (1)
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1
Dept Oncology, Leicester Royal Infirmary
Leicester, United Kingdom, LE1 2WW