A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Completion of dose escalation over 2 cycles of therapy
研究概览
简要总结
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.
详细描述
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:
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Chemotherapy only
Patients receiving up to 12 cycles of therapy. Standard care pathway management.
干预措施: Chemotherapy only (Drug)
Chemotherapy plus curcumin
Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.
干预措施: Oral complex C3 curcumin + chemotherapy (Drug)
结局指标
主要结局
Completion of dose escalation over 2 cycles of therapy
时间窗: 1 year
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.
次要结局
- Completion of (or withdrawal from) chemotherapy(Up to 6 months)
- Efficacy in terms of disease response and survival(Up to 7 years)