Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01593995
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2012-05-05
Brief Title:
EGF Ointment for Erlotinib Skin Lesion
Sponsor:
Dong-A University Hospital
Organization:
Dong-A University Hospital
Study Overview
Official Title:
Phase II Trial of Epidermal Growth Factor Ointment for Patients With Erlotinib Related Skin Effects
Status:
COMPLETED
Status Verified Date:
2014-11
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:
Epidermal growth factor receptor-tyrosin kinase inhibitor EGFR-TKI Erlotinib has demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer But their use is associated with dermatologic reactions of varying severity Incidence of Erlotinib related skin effect ERSE was reported 75 in NSCLC and pancreatic cancer phase III trials Even though the dermatologic reactions could be a surrogated marker it may be cause of dose modification Also it could give significant physical and psycho-social discomfort to patients However there is still a wide variety of drugs used- including steroid antibiotics and vitamin D without any clear evidence based management recommendation
The role of epidermal growth factor EGF has been extensively investigated in normal and pathological wound healing It is implicated in keratinocyte migration fibroblast function and the formation of granulation tissue The first growth factor to be isolated growth factor therapy has progressed into clinical practice in the treatment of wounds
Therefore the investigators propose an epidermal growth factor ointment apply for patients with Erlotinib related skin effects
The role of epidermal growth factor EGF has been extensively investigated in normal and pathological wound healing It is implicated in keratinocyte migration fibroblast function and the formation of granulation tissue The first growth factor to be isolated growth factor therapy has progressed into clinical practice in the treatment of wounds
Therefore the investigators propose an epidermal growth factor ointment apply for patients with Erlotinib related skin effects
Detailed Description:
Erlotinib
Advances in the knowledge of tumor biology and mechanisms of oncogenesis has granted the singling out of several molecular targets for NSCLC treatment Among these targets epidermal growth factor receptor EGFR or HER1 has received particular attention in lung cancer treatment EGFR is a transmembrane receptor found primarily on cells of epithelial origin Autophosphorylation of its intracellular domain initiates a cascade of events leading to cell proliferation EGFR is commonly expressed at a high level in a variety of solid tumors and it has been implicated in the control of cell survival proliferation metastasis and angiogenesis The main pharmacological strategies in clinical development for therapeutic inhibition of EGFR are monoclonal antibodies to antagonize ligand-receptor binding and small-molecules to inhibit tyrosine kinase domain activation The main EGFR inhibitors are cetuximab an anti-EGFR monoclonal antibody and Erlotinib an EGFRtyrosine kinase inhibitor The key indications for clinical use are colorectal cancer and head and neck cancer for cetuximab and NSCLC for Erlotinib Erlotinib a quinazolin-4-amine is a highly potent orally available reversible inhibitor of EGFR tyrosine kinase Erlotinib in a phase III randomized placebo-controlled trial has been proven to prolong survival 67 months versus 47 months for Erlotinib and for placebo respectively p 0001 in NSCLC patients after first or second line chemotherapy The analysis of quality of life and time to deterioration of patients reported symptoms showed statistically and clinically meaningful benefit for patients randomized to Erlotinib Moreover Erlotinib resulted active response rate of 89 and safe only 5 of patients discontinued treatment for toxicity Following this trial Erlotinib has been approved by Food and Drug Administration and Committee for Medicinal Products for Human use in chemotherapy-pretreated advanced NSCLC Skin rash is a common side-effect of all HER1EGFR inhibitors
EGF ointment
Rash affecting the skin above the waist is the most common adverse event associated with Erlotinib and generally develops within 7-10 days of starting treatment Skin rash may spontaneously resolve and reappear and it is reversible following drug discontinuation However when it develops this chronic side-effect is very distressing for the patient The increasing use of EGFR-targeted agents and specifically of Erlotinib in NSCLC treatment and simultaneously the lack of clinical trials on this topic makes rash management and etiology investigation high priorities
It has been reported that repeated treatment with EGF increases the epithelial cell proliferation in a dose dependent manner and accelerates the wound healing process whereas a single EGF treatment has no noticeable effect on the wound-healing rate There have been many studies aimed at developing a topical formulation with the sustained and stable pharmacological properties of recombinant human EGF rhEGF And the rh-EGF concentration between 1 and 5 ugg can be seen as the ideal concentration to achieve the most efficient results for acute wounds with partial thickness defects
Advances in the knowledge of tumor biology and mechanisms of oncogenesis has granted the singling out of several molecular targets for NSCLC treatment Among these targets epidermal growth factor receptor EGFR or HER1 has received particular attention in lung cancer treatment EGFR is a transmembrane receptor found primarily on cells of epithelial origin Autophosphorylation of its intracellular domain initiates a cascade of events leading to cell proliferation EGFR is commonly expressed at a high level in a variety of solid tumors and it has been implicated in the control of cell survival proliferation metastasis and angiogenesis The main pharmacological strategies in clinical development for therapeutic inhibition of EGFR are monoclonal antibodies to antagonize ligand-receptor binding and small-molecules to inhibit tyrosine kinase domain activation The main EGFR inhibitors are cetuximab an anti-EGFR monoclonal antibody and Erlotinib an EGFRtyrosine kinase inhibitor The key indications for clinical use are colorectal cancer and head and neck cancer for cetuximab and NSCLC for Erlotinib Erlotinib a quinazolin-4-amine is a highly potent orally available reversible inhibitor of EGFR tyrosine kinase Erlotinib in a phase III randomized placebo-controlled trial has been proven to prolong survival 67 months versus 47 months for Erlotinib and for placebo respectively p 0001 in NSCLC patients after first or second line chemotherapy The analysis of quality of life and time to deterioration of patients reported symptoms showed statistically and clinically meaningful benefit for patients randomized to Erlotinib Moreover Erlotinib resulted active response rate of 89 and safe only 5 of patients discontinued treatment for toxicity Following this trial Erlotinib has been approved by Food and Drug Administration and Committee for Medicinal Products for Human use in chemotherapy-pretreated advanced NSCLC Skin rash is a common side-effect of all HER1EGFR inhibitors
EGF ointment
Rash affecting the skin above the waist is the most common adverse event associated with Erlotinib and generally develops within 7-10 days of starting treatment Skin rash may spontaneously resolve and reappear and it is reversible following drug discontinuation However when it develops this chronic side-effect is very distressing for the patient The increasing use of EGFR-targeted agents and specifically of Erlotinib in NSCLC treatment and simultaneously the lack of clinical trials on this topic makes rash management and etiology investigation high priorities
It has been reported that repeated treatment with EGF increases the epithelial cell proliferation in a dose dependent manner and accelerates the wound healing process whereas a single EGF treatment has no noticeable effect on the wound-healing rate There have been many studies aimed at developing a topical formulation with the sustained and stable pharmacological properties of recombinant human EGF rhEGF And the rh-EGF concentration between 1 and 5 ugg can be seen as the ideal concentration to achieve the most efficient results for acute wounds with partial thickness defects
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