1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||1% Topical Pimecrolimus Cream for the Prevention of Rash Associated With the Use of the EGFR Antagonist, Cetuximab|
- Prevention of cetuximab rash [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]To determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.
- Quality of Life [ Time Frame: Baseline, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]To determine the effect of the rash on quality of life of patients, as determined by the Dermatology Life Quality Index (DLQI) scores at the end of two weeks of treatment.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Investigational Cream/Placebo Cream
Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. 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.
Pimecrolimus 1% topical cream twice daily for four weeks.
Other Name: Elidel
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|Contact: Lea Morris-Lane, RNfirstname.lastname@example.org|
|Contact: Govardhanan Nagaiah, MDemail@example.com|
|United States, West Virginia|
|West Virginia University Hospitals Mary Babb Randolph Cancer Center||Recruiting|
|Morgantown, West Virginia, United States, 26506|
|Contact: Lea Morris-Lane, RN 304-293-2633 firstname.lastname@example.org|
|Contact: Govardhanan Nagaiah, MD 304-293-4299 email@example.com|
|Principal Investigator: Mohammed Almubarak, MD|
|Sub-Investigator: Govardhanan Nagaiah, MD|
|Sub-Investigator: Quoc Truong, MD|
|Sub-Investigator: Bobby Chawla, MD|
|Sub-Investigator: Sobha Kurian, MD|
|Sub-Investigator: Miklos Auber, MD|
|Sub-Investigator: Scot Remick, MD|
|Sub-Investigator: Zachary Zinn, MD|
|Sub-Investigator: Lisa Giblin Sutton, PharmD|
|Sub-Investigator: Gerry Hobbs, PhD|
|Sub-Investigator: Manish Monga, MD|
|Sub-Investigator: Brendan Curley, MD|
|Sub-Investigator: Farhad Khimani, MD|
|Principal Investigator:||Mohammed Almubarak, MD||West Virginia University|
|Study Chair:||Govardhanan Nagaiah, MBBS||West Virginia University|