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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by West Virginia University
Sponsor:
Information provided by (Responsible Party):
Mohammed Almubarak, MD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01692626
First received: July 11, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Rash
Drug: Pimecrolimus
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Pimecrolimus
Pimecrolimus 1% topical cream twice daily for four weeks.
Other Name: Elidel

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692626

Contacts
Contact: Lea Morris-Lane, RN 304-293-2633 jmorrislane@hsc.wvu.edu
Contact: Brendan Curley, DO 304-293-4229 bcurley@hsc.wvu.edu

Locations
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    jmorrislane@hsc.wvu.edu   
Contact: Govardhanan Nagaiah, MD    304-293-4299    gnagaiah@hsc.wvu.edu   
Principal Investigator: Mohammed Almubarak, 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         
Sponsors and Collaborators
Mohammed Almubarak, MD
Investigators
Principal Investigator: Mohammed Almubarak, MD West Virginia University
  More Information

Publications:
Responsible Party: Mohammed Almubarak, MD, Assistant Professor (Principal Investigator), West Virginia University
ClinicalTrials.gov Identifier: NCT01692626     History of Changes
Other Study ID Numbers: WVU21011
Study First Received: July 11, 2012
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Cetuximab rash
Erbitux rash
Rash
Pimecrolimus
1% Topical pimecrolimus cream

Additional relevant MeSH terms:
Cetuximab
Pimecrolimus
Tacrolimus
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014