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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mohammed Almubarak, MD; West Virginia University
• Treatments: Cetuximab; Pimecrolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patient is starting treatment with cetuximab at the WVU Cancer Center

• Patient has advanced (unresectable or metastatic) malignancy

• Patient is expected to remain on cetuximab treatment for at least 2 weeks after enrollment on study.

• Patients should be 18 years or older

• Patients should not have a known contraindication to topical pimecrolimus therapy

• Patients should have given written informed consent

• Sexually active men and women of child bearing potential agree to use an effective method of contraception during study participation and for three months afterwards.

• Negative pregnancy test for woman of child bearing potential

Exclusion Criteria:

• Known allergy to topical pimecrolimus.

• Patients with active or recent (within one month) infection in face

• Psoriasis, eczema or others skin conditions not related to cetuximab involving face

• Pregnant or nursing women