A Phase III Study of Dapsone Gel versus Moisturizer (Placebo) to Treat Cetuximab-Related Rash

Protocol
13-012
Full Title
A Phase III randomized double-blind study of prophylactic topical dapsone 5% gel versus moisturizer for cetuximab-induced papulopustular (acneiform) rash in patients with mCRC or HNSCC without previous or concurrent RT
Phase
III
Purpose

Cetuximab is a chemotherapy drug used to treat head and neck cancer and advanced colorectal cancer. Cetuximab often causes a painful and itchy acne-like rash on the face and body. In some patients, the rash can become severe and uncomfortable enough that their cetuximab dose may need to be reduced or even temporarily withheld, potentially impacting the effectiveness of their cancer treatment.

In this study, researchers want to assess the ability of a topical medication (dapsone gel) to prevent the acne-like rash of cetuximab in patients with cancer.

Dapsone gel is already approved to treat acne. Patients will be randomly assigned to apply dapsone gel to the left or right side of the face and chest, and a moisturizer (placebo) to the other side of the face and chest. All patients will also take oral antibiotics, as this has previously been shown in clinical trials to be useful for treating the acne-like rash caused by cetuximab.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be candidates for therapy with cetuximab for head and neck squamous cell cancer or advanced colorectal cancer.
  • Patients who received or who are receiving radiation therapy to the head, neck, or chest may not participate.
  • This study is open to patients age 18 and older.

For more information about this study, please contact Dr. Mario Lacouture at 212-610-0079.

Disease(s)
Colorectal Cancer
Head & Neck Cancer
Locations