Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients With an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash

This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.

PRIMARY OBJECTIVES:

I. To demonstrate that topical ketoconazole, an anti-androgen, palliates EGFR inhibitor-induced rash within a group of racially diverse cancer patients.

II. To explore the role of ribonucleic acid (RNA) sequencing to identify other targets that might be used at a later date for rash palliation.

III. To evaluate toxicities associated with topical ketoconazole.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants apply ketoconazole topically twice daily (BID) on days 1-28.

ARM II: Participants apply placebo topically BID on days 1-28.

After completion of study treatment, participants are followed up at 1 week.

Inclusion Criteria:

• Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
• Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart =< 14 days of registration and continue for at least 28 days
• Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
• Patient must complete baseline quality of life (QOL) packet

Exclusion Criteria:

• Patient has a prior allergy or intolerance of ketoconazole
• Patient has an allergy or intolerance to sulfites