Lung CancerPhase 1CURCUMINNCT02321293
A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC
A Phase 1 study testing CurcuVIVA™, Tyrosine Kinase Inhibitor gefitinib (Iressa) and Tyrosine Kinase Inhibitor erlotinib (Tarceva) in people with Lung Cancer, run by Lady Davis Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CurcuVIVA™, Tyrosine Kinase Inhibitor gefitinib (Iressa) and Tyrosine Kinase Inhibitor erlotinib (Tarceva)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage 4.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Peter Brojge Lung Cancer Center, Jewish General Hospital
Montreal, Quebec, H3T 1E2
Victor Cohen, MD,CM, FRCPC, 514-340-8222 ext. 3878, vcohen@jgh.mcgill.ca
Goulnar Kasymjanova, MD, 514-340-8222 ext. 4312, gkasymja@jgh.mcgill.ca
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- CurcuVIVA™, Tyrosine Kinase Inhibitor gefitinib (Iressa), Tyrosine Kinase Inhibitor erlotinib (Tarceva)
- Keywords
- curcumin, lung cancer, TKI
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuVIVA™Dietary supplement
Also called Curcumin
80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability
Tyrosine Kinase Inhibitor gefitinib (Iressa)Drug
Also called gefitinib (Iressa)
250 mg PO daily until progression
Tyrosine Kinase Inhibitor erlotinib (Tarceva)Drug
Also called erlotinib (Tarceva)
150 mg PO daily until progression
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg .
2. 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. Receives: Dietary Supplement: CurcuVIVA™; Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa); Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks
safety number of side effects
Safety will be assessed by number of side effects
Measured: 16 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital
- Responsible party
- Principal investigator, Dr. Victor Cohen, Lady Davis Institute
- Investigators
- Victor Cohen, MD, Principal investigator, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321293
- Sponsor's protocol ID
- JGH-14-149
- Acronym
- CURCUMIN
- Status last verified
- Sep 2015
- First submitted
- 1 Dec 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02321293
- Acronym / sponsor ID
- CURCUMIN / JGH-14-149
- Conditions
- Lung Cancer
- Keywords
- curcumin, lung cancer, TKI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Jewish General Hospital
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: CurcuVIVA™, Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa), Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva)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: 1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg . 2. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage 4.
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuVIVA™Also: Curcumin80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability | Dietary supplement | 1 |
| Tyrosine Kinase Inhibitor gefitinib (Iressa)Also: gefitinib (Iressa)250 mg PO daily until progression | Drug | 1 |
| Tyrosine Kinase Inhibitor erlotinib (Tarceva)Also: erlotinib (Tarceva)150 mg PO daily until progression | Drug | 1 |
Primary outcome
feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires
safety number of side effects
Time frame: 16 weeks
Safety will be assessed by number of side effects
2 secondary outcomes
To evaluate and compare the changes in health-related quality of life before and after
Time frame: 8 weeks
To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Cohen, MD principal investigator
Lady Davis Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CurcuVIVA™, Tyrosine Kinase Inhibitor gefitinib (Iressa) and Tyrosine Kinase Inhibitor erlotinib (Tarceva) in people with Lung Cancer, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Cohen, MD (514-340-8222 ext. 3877, vcohen@jgh.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients, (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.