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

Northwestern University

Status and phase: Terminated; Phase 2

Conditions: Acneiform Rash; Papulopustular Eruption

Treatments: Drug: Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03115567

JNC06142016

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Triamcinolone