Clinical Trial: A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption

Brief Summary: This randomized, controlled, phase II clinical study is designed to assess the efficacy of preemptive treatment with topical steroids in preventing the papulopustular eruption induced by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients. Participants will be followed up for 6 weeks of twice daily application of triamcinolone cream to the face, chest, and back.

Detailed Summary:
Sponsor: Northwestern University

Current Primary Outcome: % of participants with grade 2 rash or higher [ Time Frame: 6 weeks ]

To assess the difference in percentage of participants who develop a grade 2 or greater rash in the control group as compared to the case group of preemptive treatment with topical steroids (triamcinolone 0.1% cream for application to face, chest and back) when administered concomitantly for 6 weeks with erlotinib, cetuximab, panitumumab, or afatinib to prevent papulopustular eruptions.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Difference in rash severity using the NCI-CTCAE 4.03 grading criteria [ Time Frame: 6 weeks ]
    To assess the difference in maximum severity of rash between the preemptive treatment group and the reactive treatment group.
  • Concordance of rash grading between NCI-CTCAE and Lacouture grading scale [ Time Frame: 6 weeks ]
    To assess the concordance of rash severity grading between the NCI-CTCAE grading system (grade 1-5 ) and those of Lacouture et al. (1a, 1b, 2a, 2b, 3a,3b), and global rash severity (grade 1-3) based on photographic analysis.
  • Change in quality of life using FACT-EGFRI 18 quality of life assessment [ Time Frame: 6 weeks ]
    To assess the difference in change in quality-of-life due to rash between the two treatment groups.
  • Number of participants in the treatment and control group who adhere to their chemotherapy regimen determined by whether patients discontinue their chemotherapy regimen or continue their full course of treatment [ Time Frame: 6 weeks ]
    This measure is to determine if the control group discontinues their chemotherapy regimen more often than the treatment group


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: February 15, 2017
Date Started: February 16, 2017
Date Completion: January 2018
Last Updated: April 11, 2017
Last Verified: April 2017