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

NCT03115567 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: JNC06142016
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Acneiform Rash; Papulopustular Eruption

Outcome Measures

Primary Outcomes (1)

• % of Participants With Grade 2 Rash or Higher

  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.

  6 weeks

Secondary Outcomes (2)

• Change in Quality of Life Using FACT-EGFRI 18 Quality of Life Assessment

  6 weeks

• 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

  6 weeks

Study Arms (2)

Control

NO INTERVENTION

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.

Triamcinolone

EXPERIMENTAL

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.

Drug: Triamcinolone

Interventions

Triamcinolone DRUG

6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.

Triamcinolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 20145956 BACKGROUND

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dermatology CTU
• Organization: Northwestern University

NUderm-research@northwestern.edu

312-503-5944

Study Officials

• Jennifer N Choi, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Oncodermatology

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: April 14, 2017
• Study Start: February 16, 2017
• Primary Completion: April 24, 2020
• Study Completion: September 2, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)