Topic: National Cancer Research Network
Conditions
Interventions
This study is the first to combine daily oral curcumin with standard care FOLFOX-based (5-fluorouracil, folinic acid and oxaliplatin) chemotherapy in colorectal cancer patients with inoperable liver m
Sponsors
University of Leicester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological or cytological diagnosis of metastatic colorectal cancer 2. Measurable disease by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) 3. Adequate haematological, hepatic and renal function 4. Age more than or equal to 18 years 5. Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1 6. Patients must have recovered from effects of any recent major surgery 7. Willing to use contraception if applicable 8. Informed consent 9. Life expectancy estimated to be more than 12 weeks; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
Exclusion criteria
Exclusion criteria: 1.Contraindications to FOLFOX chemotherapy: Peripheral neuropathy National Cancer Institute Common Toxicity Criteria (NCI CTC) >1, Liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months. 2. Unwilling or unable to comply with the study protocol 3. 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. 4. Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug study. 5. Previous cancer <5 years (other than colorectal, basal cell carcinoma, in-situ cervical cancer) 6. Major surgery within 4 weeks of starting the study 7. Co-existing active infection or serious concurrent medical condition 8. Significant cardiovascular disease 9. Bone metastases 10. Known brain or leptomeningeal metastases 11. Surgery or hospital admissions for symptomatic intra-abdominal adhesions 12. Active endoscopically proven peptic ulcer disease or colitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; Timepoint(s): Real-time adverse event reporting using Common Terminology Criteria for Adverse Events (CTC-AE), diaries and direct consultation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biomarker Discovery; Timepoint(s): Samples taken during treatment phase 1-2years. Analysis 3-4 years. 2. Efficacy; Timepoint(s): Measured by response (RECIST) and survival 3. Measurement of systemic curcumin; Timepoint(s): During treatment phase 4. Neurotoxic side-effects; Timepoint(s): 2 weekly neurotoxicity questionnaires 5. Tolerability/Establishing Target Dose; Timepoint(s): Completion dose escalation phase of 3 consecutive patients without dose-limiting toxicitiy 2 cycles | — |
Countries
United Kingdom
Outcome results
None listed