Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW 2992
Recruitment status was: Recruiting
- Advanced NSCLC have a poor prognosis and the positive impact of chemotherapy is limited by the development of intrinsic and acquired resistance.
- Over the past decade, less toxic agents such as the innovative targeted therapies, i.e. erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good quality of life with a low toxicity
- BIBW 2992, an aniline-quinazoline, is an EGFR and HER-2 irreversible inhibitor, and it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2
- This molecule have shown benefits as a single agent in pre-treated patients who have progressed despite platinum-based chemotherapy, with a minimal toxicity compared to chemotherapy
- BIBW 2992 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 in patients and lead to inconsistent EGFR inhibitor dose administration
- There is no a standard treatment for rash, but case reports have tried to demonstrate the benefit obtained with alcohol-free emollients, sunscreen with titanium dioxide or antibiotic (topic or oral) treatment such as clindamycin or doxycycline, anti-inflammatory drugs such as steroids and isotretinoin in the treatment of these cutaneous injuries.
- 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 BIBW 2992
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|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|
- Incidence and severity of rash [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]From the day of initiation of BIBW 2992, we will register the incidence and grade of toxicity at baseline time, 2 weeks, 4 weeks and 8 weeks according to the CTCAE V4.0
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]A QLQ questionnaire from EORTC organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression
- rash and progression free-survival [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]The measure will be from the start of consumption to the first documented evidence of progression according to the RECIST criteria, or if patients still survive the measure will be made after 24 weeks
- Rash and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]From the start of consumption of BIBW 2992 to the date of death or last contact
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Patients will receive tetracycline 250mg every 24 hrs for 1 month plus general dermatological recommendations (sunscreen and emollient cream)
The experimental group will receive tetracycline 250mg every 24hrs for 1 month the same day at initiation of BIBW 2992
No Intervention: No Tetracycline
This arm only with general dermatologic recommendations. Patients in this arm can receive tetrayclines only if rash grade 3-4 occur during therapy
Case reports have tried to demonstrate the benefit obtained with alcohol-free emollients used 2-3 times daily, sunscreen with titanium dioxide or zinc oxide with a SPF greater than 15, antibiotic (topic or oral) treatment (such as clindamycin, metronidazole, tetracyclines) secondary to infection and steroidal anti-inflammatory drugs (betamethasone, triamcinolone) and isotretinoin in the treatment of these cutaneous injuries.
The objective for this project is to evaluate whether prophylactic treatment with tetracycline can reduce dermatological occurrences such as rash, induced by EGFR and HER-2 tyrosine kinase inhibitor BIBW 2992 in patients with non-small cell lung cancer, and improve the patient's quality of life.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01880515
|Instituto Nacional de Cancerología|
|México, D.F., Mexico city, Mexico, 14080|
|Principal Investigator:||Oscar Arrieta, M.D., M.Sc.||Instituto Nacional de Cancerología|