ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02321293
Recruitment Status : Unknown
Verified September 2015 by Dr. Victor Cohen, Lady Davis Institute.
Recruitment status was:  Recruiting
First Posted : December 22, 2014
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
Jewish General Hospital
Information provided by (Responsible Party):
Dr. Victor Cohen, Lady Davis Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Dietary Supplement: CurcuVIVA™ Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa) Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva) Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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:

  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.

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

Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa)
250 mg PO daily until progression
Other Name: gefitinib (Iressa)

Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva)
150 mg PO daily until progression
Other Name: erlotinib (Tarceva)




Primary Outcome Measures :
  1. 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,


  2. 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

  3. 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

  4. 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

  5. safety number of side effects [ Time Frame: 16 weeks ]
    Safety will be assessed by number of side effects


Secondary Outcome Measures :
  1. To evaluate and compare the changes in health-related quality of life before and after [ Time Frame: 8 weeks ]
    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.

  2. To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein) [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321293


Contacts
Contact: Victor Cohen, MD 514-340-8222 ext 3877 vcohen@jgh.mcgill.ca
Contact: Goulnar Kasymjanova, MD 514-340-8222 ext 4312 gkasymja@jgh.mcgill.ca

Locations
Canada, Quebec
Peter Brojge Lung Cancer Center, Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Victor Cohen, MD,CM, FRCPC    514-340-8222 ext 3878    vcohen@jgh.mcgill.ca   
Contact: Goulnar Kasymjanova, MD    514-340-8222 ext 4312    gkasymja@jgh.mcgill.ca   
Sub-Investigator: Khashayar Esfahani, MD         
Sub-Investigator: Arif Awan, MD         
Sub-Investigator: Thomas R Jagoe, MD         
Sub-Investigator: Jason S Agulnik, MD         
Sub-Investigator: David Small, MD         
Sub-Investigator: Carmela Pepe, MD         
Sub-Investigator: Lama Sakr, MD         
Sub-Investigator: Goulnar Kasymjanova, MD         
Sponsors and Collaborators
Lady Davis Institute
Jewish General Hospital
Investigators
Principal Investigator: Victor Cohen, MD Lady Davis Institute

Responsible Party: Dr. Victor Cohen, MD,CM, FRCPC, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT02321293     History of Changes
Other Study ID Numbers: JGH-14-149
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Dr. Victor Cohen, Lady Davis Institute:
curcumin
lung cancer
TKI

Additional relevant MeSH terms:
Curcumin
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents