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

Lady Davis Institute

Status and phase: Unknown; Phase 1

Conditions: Lung Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02321293

JGH-14-149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa)

Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva)

Dietary Supplement: CurcuVIVA™