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

Phase 2

Terminated

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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Triamcinolone	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.

Primary Outcome Measures

Name	Time	Method
% of Participants With Grade 2 Rash or Higher	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Using FACT-EGFRI 18 Quality of Life Assessment	6 weeks	To assess the difference in change in quality-of-life due to rash at Visit 4 from Visit 1 between the two treatment groups. FACT-EGFRI 18 is an 18-question assessment for cancer patients undergoing EGFR treatment. The scoring range is 0-72, with 72 indicating more severe functional impact.
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	This measure is to determine if the control group discontinues their chemotherapy regimen more often than the treatment group