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| Name | Class |
|---|---|
| Jewish General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CurcuVIVAâ„¢ | Dietary Supplement | 80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability |
|
| Measure | Description | Time Frame |
|---|---|---|
| feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients, | 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, | 8 weeks |
| feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits | will by assessed by follow-up rate= number of actual study visits/ total number of study visits | 8 weeks |
| feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules | Adherence/Compliance rate= Number of taken capsules/Total number of capsules | 8 weeks |
| feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires | Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires | 8 weeks |
| safety number of side effects | Safety will be assessed by number of side effects | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate and compare the changes in health-related quality of life before and after | Patients' quality of life on curcumin treatment will be assessed by the FACT-L at the baseline, 4 weeks,8 weeks on concurrent curcumin and TKI and 8 weeks post-study. Clinically important difference in the score is considered 2 points. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Cohen, MD | Contact | 514-340-8222 | 3877 | vcohen@jgh.mcgill.ca |
| Goulnar Kasymjanova, MD | Contact | 514-340-8222 | 4312 | gkasymja@jgh.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Victor Cohen, MD | Lady Davis Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Brojge Lung Cancer Center, Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| Tyrosine Kinase Inhibitor gefitinib (Iressa) | Drug | 250 mg PO daily until progression |
|
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| Tyrosine Kinase Inhibitor erlotinib (Tarceva) | Drug | 150 mg PO daily until progression |
|
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| To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein) |
anti-inflammatory effects of curcumin will be assessed by measuring C-reactive protein tests will be performed at baseline, 2, 4, 8 and 16 weeks into study. |
| 8 weeks |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D000077156 | Gefitinib |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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