A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC

Lung Cancer Clinical Trial

— CURCUMIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321293
• Other study ID #: JGH-14-149
• Status: Recruiting
• Phase: Phase 1
• First received: December 1, 2014
• Last updated: September 1, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Lady Davis Institute
• Contact: Victor Cohen, MD
• Phone: 514-340-8222
• Email: vcohen[@]jgh.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Dietary Supplement:
• CurcuVIVA™
80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability

Drug:
• Tyrosine Kinase Inhibitor gefitinib (Iressa)
250 mg PO daily until progression
• Tyrosine Kinase Inhibitor erlotinib (Tarceva)
150 mg PO daily until progression

Locations

Country	Name	City	State
Canada	Peter Brojge Lung Cancer Center, Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Lady Davis Institute	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	safety number of side effects	Safety will be assessed by number of side effects	16 weeks	Yes
Secondary	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	No
Secondary	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	No