NCT02284139

Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects

Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Dong-A University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).

Detailed description

The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03. The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.

Conditions

• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Arm EGF ointment 1ppm	EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
DRUG	Arm EGF ointment 20 ppm	EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
DRUG	Arm Placebos	EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2014-11-05
• Last updated: 2018-04-23

Locations

1 site across 1 country: South Korea