Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01880515
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2013-05-31
Brief Title:
Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 Afatinib
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
Phase II Open-label Single Blind Randomised Clinical Trial With Tetracycline as a Prophylaxis for Rash and Dermatological Recommendations Versus Dermatological Recommendations in Patients With NSCLC Receiving Treatment With BIBW 2992
Status:
COMPLETED
Status Verified Date:
2023-04
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:
1 Advanced NSCLC has a poor prognosis and the positive impact of chemotherapy is limited by the development of intrinsic and acquired resistance
2 Over the past decade less toxic agents such as the innovative targeted therapies ie erlotinib or gefitinib have the potential to improve the effectiveness and keep a good quality of life with a low toxicity
3 BIBW2992 afatinib an aniline-quinazoline is an epidermal growth factor receptor EGFR and human epidermal growth factor receptor 2 HER-2 irreversible inhibitor and it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2
4 This molecule has shown benefits as a single agent in pre-treated patients who have progressed despite platinum-based chemotherapy with a minimal toxicity compared to chemotherapy
5 BIBW2992 is associated with adverse effects similar to those for erlotinib and gefitinib such as rash and diarrhea These symptoms can reduce the quality of life QL in patients and lead to inconsistent EGFR inhibitor dose administration
6 There is not a standard treatment for rash However case reports have tried to demonstrate the benefit in the treatment of these cutaneous injuries obtained with alcohol-free emollients sunscreen with titanium dioxide or antibiotic topic or oral treatment regimens that include clindamycin or doxycycline as well as anti-inflammatory drugs such as steroids and isotretinoin
7 In order to reduce the incidence and severity of cutaneous toxicities we will compare the prophylactic antibiotic treatment using tetracycline and general dermatological recommendations versus using only dermatological recommendations in patients initiating the treatment with BIBW2992
2 Over the past decade less toxic agents such as the innovative targeted therapies ie erlotinib or gefitinib have the potential to improve the effectiveness and keep a good quality of life with a low toxicity
3 BIBW2992 afatinib an aniline-quinazoline is an epidermal growth factor receptor EGFR and human epidermal growth factor receptor 2 HER-2 irreversible inhibitor and it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2
4 This molecule has shown benefits as a single agent in pre-treated patients who have progressed despite platinum-based chemotherapy with a minimal toxicity compared to chemotherapy
5 BIBW2992 is associated with adverse effects similar to those for erlotinib and gefitinib such as rash and diarrhea These symptoms can reduce the quality of life QL in patients and lead to inconsistent EGFR inhibitor dose administration
6 There is not a standard treatment for rash However case reports have tried to demonstrate the benefit in the treatment of these cutaneous injuries obtained with alcohol-free emollients sunscreen with titanium dioxide or antibiotic topic or oral treatment regimens that include clindamycin or doxycycline as well as anti-inflammatory drugs such as steroids and isotretinoin
7 In order to reduce the incidence and severity of cutaneous toxicities we will compare the prophylactic antibiotic treatment using tetracycline and general dermatological recommendations versus using only dermatological recommendations in patients initiating the treatment with BIBW2992
Detailed Description:
Case reports have tried to demonstrate the benefit in the treatment of rash obtained with alcohol-free emollients used 2-3 times daily sunscreen with titanium dioxide or zinc oxide with a skin protection factor SPF greater than 15 topic or oral antibiotic regimens such as clindamycin metronidazole tetracyclines when there is secondary infection as well as steroidal anti-inflammatory drugs betamethasone triamcinolone and isotretinoin
The objective of this project is to evaluate whether the prophylactic treatment with tetracycline can reduce dermatological toxicities such as rash induced by the EGFR and HER-2 tyrosine kinase inhibitor BIBW 2992 in patients with non-small cell lung cancer
The objective of this project is to evaluate whether the prophylactic treatment with tetracycline can reduce dermatological toxicities such as rash induced by the EGFR and HER-2 tyrosine kinase inhibitor BIBW 2992 in patients with non-small cell lung cancer
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