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

NCT01692626 | Terminated Phase 2 Results DMC

• 1 other identifier: WVU21011
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Rash

Keywords

Cetuximab rash; Erbitux rash; Rash; Pimecrolimus; 1% Topical pimecrolimus cream

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 weeks

Study Arms (2)

Pimecrolimus on Left vs. Placebo on Right

EXPERIMENTAL

Patients 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.

Drug: Pimecrolimus; Drug: Placebo

Pimecrolimus on Right vs. Placebo on Left

EXPERIMENTAL

Patients 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.

Drug: Pimecrolimus; Drug: Placebo

Interventions

Pimecrolimus DRUG

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

Also known as: Elidel

Pimecrolimus on Left vs. Placebo on Right; Pimecrolimus on Right vs. Placebo on Left

Placebo DRUG

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

Pimecrolimus on Left vs. Placebo on Right; Pimecrolimus on Right vs. Placebo on Left

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

Related Publications (4)

• 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.

  PMID: 7612182 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.

  PMID: 8899291 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.

  PMID: 21505590 BACKGROUND

MeSH Terms

Conditions

Exanthema

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Changed Status to Terminated to indicate study closed early

Results Point of Contact

• Title: Mohammed Almubarak, MD, Assistant Professor
• Organization: West Virginia University

malmubarak@hsc.wvu.edu

304-293-4229

Study Officials

• Mohammed Almubarak, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: September 25, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)