Recruiting
Phase 1

Curcumin & EGFR-TKIs

Sponsor:

Lady Davis Institute

Code:

NCT02321293

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CurcuVIVA™

Tyrosine Kinase Inhibitor gefitinib (Iressa)

Tyrosine Kinase Inhibitor erlotinib (Tarceva)

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT02321293

Start date

Aug, 2015

Status verified date

Sep, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Interventions and Outcome Measures

Arms

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.

Interventions

CurcuVIVA™

80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability

Tyrosine Kinase Inhibitor gefitinib (Iressa)

250 mg PO daily until progression

Tyrosine Kinase Inhibitor erlotinib (Tarceva)

150 mg PO daily until progression

Primary outcome measure

  • feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients, [ Time Frame: 8 weeks ]
  • feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits [ Time Frame: 8 weeks ]
  • feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules [ Time Frame: 8 weeks ]
  • feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires [ Time Frame: 8 weeks ]
  • safety number of side effects [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Victor Cohen, MD

514-340-8222vcohen@jgh.mcgill.ca

Goulnar Kasymjanova, MD

514-340-8222gkasymja@jgh.mcgill.ca

Locations

Peter Brojge Lung Cancer Center, Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Victor Cohen, MD,CM, FRCPC

514-340-8222vcohen@jgh.mcgill.ca

Goulnar Kasymjanova, MD

514-340-8222gkasymja@jgh.mcgill.ca

More Information

Sponsor

Lady Davis Institute

Last update posted

Sep 2, 2015

Last verified

Sep, 2015

Keywords

  • curcumin
  • lung cancer
  • TKI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lady Davis Institute on 2015-09-02.