Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer

• Status: Completed
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Treatments: Capecitabine; Curcumin

Criteria

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