Clinical Trial: 1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 1% Topical Pimecrolimus Cream for the Prevention of Rash Associated With the Use of the EGFR Antagonist, Cetuximab
Brief 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.
Detailed Summary:
Adult patients who are being treated with cetuximab for a malignancy will be offered the chance to take part in the study. Patients must provide written informed consent in order to participate in the study (including consent to clinical photographs).
The area of skin to be treated with investigational cream will be the face. Baseline photographs will be taken of the selected area of bilateral face.
Patients will be requested to apply a thin layer of the investigational cream twice daily to one half of face at the same time they are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. Patients will be provided the sufficient investigational cream free of charge for the duration of study. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator. The dermatologist and study investigators will remain blinded to the side to which the investigational cream was applied. In this manner, patients will serve as their own controls. Patients are free to use oral tetracyclines if recommended by their primary oncologists. Patients on the trial, however, cannot use another rash treatment with the exception of moisturizing agents.
Patients participating in the study will be instructed to apply a moisturizing cream, lotion, or ointment of their choice to the face three times a day. Moisturizers should be applied to the skin after, not before, the investigational cream application. Patients should not wet the treated area of skin for one hour after applying investigational cream, otherwise it could be washed
Sponsor: West Virginia University
Current Primary Outcome: Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face. [ Time Frame: 2 weeks ]
Original Primary Outcome: Prevention of cetuximab rash [ Time Frame: 2 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Quality of Life [ Time Frame: Baseline, 2 weeks and 4 weeks ]
Information By: West Virginia University
Dates:
Date Received: July 11, 2012
Date Started: February 2012
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017
