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

NCT02321293 | Unknown Phase 1

• 1 other identifier: JGH-14-149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

curcumin; lung cancer; TKI

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• To evaluate and compare the changes in health-related quality of life before and after

  8 weeks

• To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein)

  8 weeks

Study Arms (1)

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.

Dietary Supplement: CurcuVIVA™; Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa); Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva)

Interventions

CurcuVIVA™ DIETARY_SUPPLEMENT

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

Also known as: Curcumin

1

Tyrosine Kinase Inhibitor gefitinib (Iressa) DRUG

250 mg PO daily until progression

Also known as: gefitinib (Iressa)

1

Tyrosine Kinase Inhibitor erlotinib (Tarceva) DRUG

150 mg PO daily until progression

Also known as: erlotinib (Tarceva)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead
• Jewish General Hospital: collaborator

Study Sites (1)

Peter Brojge Lung Cancer Center, Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Curcumin; Gefitinib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Victor Cohen, MD

  Lady Davis Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Cohen, MD

CONTACT

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

Goulnar Kasymjanova, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,CM, FRCPC

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 22, 2014
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

CA (1)