Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02284139
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2014-11-03
Brief Title:
Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects
Sponsor:
Dong-A University Hospital
Organization:
Dong-A University Hospital
Study Overview
Official Title:
Pilot Trial of Epidermal Growth Factor EGF Ointment for the Patients With Epidermal Growth Factor Receptor EGFR Inhibitor Related Skin Side Effects
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-FUIrinotecanleucovorinLV FOLFIRI 5-FUOxaliplatinLV FOLFOX and sufficient liver kidney and bone marrow function to undergo treatment All the patients had Grade 2 ERSEs according to the National Cancer Institutes Common Terminology Criteria for Adverse Events NCI-CTCAE v 403
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None