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

Rash research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Rash

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PimecrolimusPimecrolimus 1% topical cream applied twice daily for four weeks on one side of the face.

Drug:PlaceboPlacebo cream applied twice daily for four weeks on opposite side of the face from the Pimecrolimus side.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Pimecrolimus on Left vs. Placebo on RightPatients will apply a thin layer of the Pimecrolimus 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 on Right vs. Placebo on LeftPatients will apply a thin layer of the Pimecrolimus 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.

Study Status

Terminated

Start Date: February 2012

Completed Date: April 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mohammed Almubarak, MD

Lead Sponsor: West Virginia University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01692626

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. Review.

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