Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer
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|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Completion of dose escalation over 2 cycles of therapy
time frame: 1 year
Completion of (or withdrawal from) chemotherapy
time frame: Up to 6 months
time frame: Up to 7 years
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
|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.|
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