Clinical Trial: Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer

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

Official Title: A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

Brief Summary:

The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach.

Hypothesis:

Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients.

Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients.

Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.


Detailed Summary:

Erlotinib has been shown to prolong survival in NSCLC patients who are no longer candidates for further chemotherapy. In July 2005, erlotinib was approved in Canada for the treatment of patients with locally advanced or metastatic NSCLC, following failure of first or second-line chemotherapy.

Erlotinib's side effect profile includes rash. The incidence of rash in clinical trials has been reported to be approximately 50 - 75%, and has been hypothesised to parallel tumour response (20).

The treatment of rash is controversial and many oncologists believe it is untreatable and self-limiting. The cause of the rash is not well understood but is felt to be a systemic event. Clinical experience of the investigators has suggested that minocycline 100 mg orally given twice-daily for 4 weeks and clindamycin 2% and hydrocortisone 1% topical cream for moderate to severe rash is a successful treatment.

The objectives of this trial are to better delineate the rash and its features and to describe an optimal treatment. Since the rash is often facial in distribution and can therefore lead to physical and psychological distress to the patient, a dermatology life quality index will also be completed throughout the study.


Sponsor: British Columbia Cancer Agency

Current Primary Outcome:

  • Overall Incidence of Rash [ Time Frame: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year ]

    The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.

    For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group.

  • Time Duration From Onset of Rash Until Resolution [ Time Frame: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year ]

    To investigate if the rash caused by erlotinib is self-limiting.

    A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.

    The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.

    The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2.

  • Overall Incidence of Grade 3 Rash [ Time Frame: F

    Original Primary Outcome: Overall Incidence of Rash [ Time Frame: 1 year ]

    Current Secondary Outcome:

    • Severity of Rash Caused by Erlotinib [ Time Frame: Onset until resolution, up to 4 weeks following progression, on average of 1 year ]
      The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash.
    • Overall Survival [ Time Frame: Until death ]
    • Duration of Treatment [ Time Frame: Up to one year ]
    • Time to First Presentation of Rash [ Time Frame: Up to onset of rash while on study treatment ]


    Original Secondary Outcome: To investigate if the rash caused by erlotinib is self-limiting [ Time Frame: 1 year ]

    Information By: British Columbia Cancer Agency

    Dates:
    Date Received: May 10, 2007
    Date Started: January 2009
    Date Completion:
    Last Updated: February 16, 2017
    Last Verified: February 2017