NCT02321293

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Lady Davis Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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
DRUG	Tyrosine Kinase Inhibitor erlotinib (Tarceva)	150 mg PO daily until progression

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2014-12-22
• Last updated: 2015-09-02

Locations

1 site across 1 country: Canada