Clinical Trial: Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II, Open-label, Single Blind, Randomised Clinical Trial With Tetracycline as a Prophylaxis for Rash and Dermatological Recommendations Versus Dermatological Recommen

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, i.e. 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.

    8. Detailed Summary:

    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.


    Sponsor: Instituto Nacional de Cancerologia de Mexico

    Current Primary Outcome: Frequency of Participants Who Experienced Any Grade of Rash As Characterized By The Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0 [ Time Frame: Percentage of adverse events at week 8 ]

    Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.


    Original Primary Outcome: Incidence and severity of rash [ Time Frame: 2 months ]

    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


    Current Secondary Outcome:

    • Quality of Life (QL) [ Time Frame: from baseline to 6 months ]
      A QL questionnaire from European Organization for Research and Treatment of Cancer (EORTC) organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression
    • Progression Free-survival [ Time Frame: 24 weeks from baseline ]
      The measure will be from the start of consumption to the first documented evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or if patients still survive the measure will be made after 24 weeks
    • Progression Free Survival [ Time Frame: Participants will be followed for the duration of the treatment, an average of 8 weeks. ]
      From the start of consumption of BIBW 2992 to the date progression or last follow up


    Original Secondary Outcome:

    • Quality of life [ Time Frame: 6 months ]
      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 ]
      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 ]
      From the start of consumption of BIBW 2992 to the date of death or last contact


    Information By: Instituto Nacional de Cancerologia de Mexico

    Dates:
    Date Received: May 31, 2013
    Date Started: December 2010
    Date Completion:
    Last Updated: March 1, 2017
    Last Verified: March 2017