A Phase 1 Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors for Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
研究概览
简要总结
The purpose of this study is is to assess the safety and tolerability of curcumin in combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR NSCLC.
详细描述
This is a phase 1 open prospective cohort study to assess the safety and feasibility of using curcumin in conjunction with an EGFR-TKI in patients with advanced NSCLC. The investigators will use an enhanced bioavailable formulation of curcumin (CURCUViva TM at 80 mg/ 1 capsule per day) approved and licensed by Health Canada (NPN 80027414) that has been shown to have 2-3 times higher curcumin concentration in the blood as compared to previous clinical trials. As primary objective, the investigators will recruit 20 patients for a duration of 8 weeks to monitor adverse effects according to the the National Cancer Institute Common Terminology Criteria.Exploratory objectives would include assessing changes in health-related quality of life using the standardized FACT-L questionnaire and evaluating anti-inflammatory properties of curcumin by measuring CRP. If tolerable safety data is obtained, an expanded phase II trial will be designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage
- •The EGFR mutation analysis must be performed prior to enrolment into the trial (i.e., before a patient is consented). Any EGFR mutation-positive result must be documented and the analysis for the mutation will be performed using the JGH local testing methodology.
- •Receiving concurrent EGFR-TKI therapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score 0-3
排除标准
- •Symptomatic brain metastases.
- •Patients who are receiving any other investigational agents.
- •Patients using other non-vitamin or mineral regular natural health product, which includes Chinese Herbs.
- •Incapacity to understand and sign a written informed consent document in English/French.
- •Pregnancy
研究组 & 干预措施
1
CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy.
CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin)
Tyrosine Kinase Inhibitors:
- Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg .
- Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg .
Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.
干预措施: CurcuVIVA™ (Dietary Supplement)
1
CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy.
CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin)
Tyrosine Kinase Inhibitors:
- Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg .
- Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg .
Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.
干预措施: Tyrosine Kinase Inhibitor gefitinib (Iressa) (Drug)
1
CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy.
CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin)
Tyrosine Kinase Inhibitors:
- Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg .
- Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg .
Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.
干预措施: Tyrosine Kinase Inhibitor erlotinib (Tarceva) (Drug)
结局指标
主要结局
feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
时间窗: 8 weeks
Feasibility will determine whether the use of curcumin is appropriate for further testing; and will be assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits
时间窗: 8 weeks
will by assessed by follow-up rate= number of actual study visits/ total number of study visits
feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules
时间窗: 8 weeks
Adherence/Compliance rate= Number of taken capsules/Total number of capsules
feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires
时间窗: 8 weeks
Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires
safety number of side effects
时间窗: 16 weeks
Safety will be assessed by number of side effects
次要结局
- To evaluate and compare the changes in health-related quality of life before and after(8 weeks)
- To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein)(8 weeks)
研究者
Dr. Victor Cohen
MD,CM, FRCPC
Lady Davis Institute