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

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ClinicalTrials.gov Identifier: NCT03115567
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Nam Choi, MD, Northwestern University

February 15, 2017
April 14, 2017
March 6, 2018
February 16, 2017
January 2019   (Final data collection date for primary outcome measure)
% 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.
Same as current
Complete list of historical versions of study NCT03115567 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption
A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Acneiform Rash
  • Papulopustular Eruption
Drug: Triamcinolone
6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
  • No Intervention: Control
    Patients in Control group will be instructed to follow a daily moisturizer and sunscreen regimen. Erlotinib, cetuximab, panitumumab, or afatinib will be administered as standard of care treatment.
  • Experimental: Triamcinolone
    Patients in the Triamcinolone group will be applying Triamcinolone 0.1% cream daily to their face, chest, and upper back, in addition to adhering to the same daily moisturizer and sunscreen regimen of the Control group. Erlotinib, cetuximab, panitumumab, or afatinib will be administered concomitantly as standard of care treatment.
    Intervention: Drug: Triamcinolone
Lacouture ME, Maitland ML, Segaert S, Setser A, Baran R, Fox LP, Epstein JB, Barasch A, Einhorn L, Wagner L, West DP, Rapoport BL, Kris MG, Basch E, Eaby B, Kurtin S, Olsen EA, Chen A, Dancey JE, Trotti A. A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity study group. Support Care Cancer. 2010 Apr;18(4):509-22. doi: 10.1007/s00520-009-0744-x. Epub 2010 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
Same as current
January 2019
January 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a histologically or cytologically confirmed cancer diagnosis for which EGFRI treatment is indicated
  • Initiation of topical steroids or control treatment within 3 days of initiation of cetuximab, erlotinib, panitumumab, or afatinib
  • Patients must be age ≥ 18 years.
  • Life expectancy of greater than 6 weeks
  • Patient able to use topical medications reliably and complete questionnaires with assistance if needed
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.

Exclusion Criteria:

  • Patients who have used systemic or topical steroids within 7 days of trial registration, or start systemic or topical steroids for reasons unrelated to trial during the 6-week follow up period
  • Patients who have used antibiotics within 7 days of trial registration, or start antibiotics for other conditions during the 6-week follow up period
  • History of allergic reactions to topical steroids
  • Patients with any rash at the time of study registration
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients using any other topical medications in the treatment areas (face, chest, or back).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Linda Serrano, MD 312-503-5903 NUOncoderm@northwestern.edu
United States
 
 
NCT03115567
JNC06142016
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Jennifer Nam Choi, MD, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Jennifer N Choi, MD Northwestern University
Northwestern University
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP