A Phase II, Randomized, Double-Blind, Split-Face of Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors
University of Utah
Summary
The goal of this clinical trial is to learn if using topical tretinoin will help patients with solid tumors who are experiencing an acneiform rash as a side effect of their treatment. Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact.
Description
The anti-epidermal growth factor receptor (anti-EGFR) agents cetuximab and panitumumab have been shown in numerous trials to be active in patients with metastatic colorectal cancer (mCRC). Current American Society of Clinical Oncology guidelines strongly recommend offering an antiEGFR therapy in combination with chemotherapy to patients with treatment-naïve, left-sided, RAS wild-type mCRC. In addition to colorectal cancer, anti-EGFR agents are also approved for use in the management of head and neck, cutaneous squamous cell, and penile cancers. Novel prophylactic approaches are needed so that…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant aged ≥ 18 years * Histologically confirmed solid tumor. * Radiologically confirmed locally advanced or metastatic disease. * Eligible for and willing to receive treatment with panitumumab or cetuximab as standard-of-care. * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: --Hepatic: * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN. * Negative pregnancy test for participan…
Interventions
- DrugTopical Tretinoin
Topical tretinoin will be applied to one half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.
- OtherPlacebo
A placebo (topical moisturizer) will be applied to the other half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.
Location
- Huntsman Cancer Institute at University of UtahSalt Lake City, Utah