1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX

Summary

When cancer patients are treated with the drug cetuximab they very often develop a rash. Usually it appears on their face and back and other parts of the body. The rash looks like acne and is treated with skin creams or antibiotics most of the time. The rash can become very painful and cause patients to stop using cetuximab to treat their cancer, even if cetuximab was helping fight their cancer. Cetuximab is known to be a good drug to help treat cancer. This study will help us learn about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel) to see if it will help prevent the rash or keep the rash from getting worse. The investigators also want to see how the rash affects patients and their quality of life. Participants will be in this study for about four weeks if their rash does not get worse. They will need to apply the study cream and placebo two times daily and answer quality of life questionnaires during this study. Participants will also be seen by a dermatologist and have pictures taken of their rash.

Timeline

Start

2012-02

Primary completion

2014-04

Completion

2014-04

Publications

• Background Salomon DS, Brandt R, Ciardiello F, Normanno N. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol. 1995 Jul;19(3):183-232. doi: 10.1016/1040-8428(94)00144-i. No abstract available.
• Background Rusch V, Mendelsohn J, Dmitrovsky E. The epidermal growth factor receptor and its ligands as therapeutic targets in human tumors. Cytokine Growth Factor Rev. 1996 Aug;7(2):133-41. doi: 10.1016/1359-6101(96)00016-0.
• Background Clark, R. Perez-Soler, L. Siu, A. Gordon and P. Santabarbara. Rash severity is predictive of increased survival with erlotinib HCl [abstract 786]. Proc Am Soc Clin Oncol 22 (2003),:p. 196.
• Background Mittmann N, Seung SJ. Rash rates with egfr inhibitors: meta-analysis. Curr Oncol. 2011 Apr;18(2):e54-63. doi: 10.3747/co.v18i2.605.

Drugs

Indications