Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01299220
Recruitment Status : Withdrawn (Unable to enroll subjects by sponsor deadline)
First Posted : February 18, 2011
Last Update Posted : January 16, 2013
OSI Pharmaceuticals
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
This study will look at if a low-dose regimen of acitretin is helpful in treating a skin rash caused by the chemotherapy drug, erlotinib.

Condition or disease Intervention/treatment Phase
Skin Rash Drug: Acitretin Phase 4

Detailed Description:

This is a pilot trial with an initial target sample of 32 evaluable subjects. The study will last up to 12 weeks per subject and up to 9 months for the entire study. Cancer patients beginning antineoplastic therapy with the EGFR inhibitor erlotinib will be enrolled in this trial. Patients beginning erlotinib therapy will simultaneously initiate a skin care regimen consisting of twice daily application of Eucerin,TM Aveeno,TM or CeraveTM moisturizing cream and daily application of SPF 15 or greater sunscreen.

Those patients who develop rash of CTCAE Grade 2 or higher will be referred to us by their primary oncologist. Upon onset of the cutaneous eruption, the oncologist will initiate therapy with doxycycline (100 mg twice daily; those allergic to doxycycline will instead receive cephalexin, 250 mg twice daily).

On evaluation by the Principal Investigator, patients with insufficient response to a two week course of doxycycline (continued CTCAE Grade 2 or higher rash) will begin therapy with low-dose acitretin (10 mg/day). Patients will continue to receive 10 mg/day acitretin and will be followed for 12 weeks, after which they will be treated off-study according to an individualized regimen agreed upon by the patient and treating oncologist.

Patients who continue to have unacceptable skin eruptions and who require off-study dose reduction or interruption of erlotinib despite acitretin treatment, as well as those patients who develop CTCAE Grade 3 or higher toxicity presumptively due to acitretin, will be considered non-responders for this study. These patients will be treated off-study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Acitretin for Treatment of Erlotinib-induced Skin Rash
Study Start Date : November 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
U.S. FDA Resources

Intervention Details:
    Drug: Acitretin
    Acitretin 10 mg by mouth daily
    Other Name: Soriatane

Primary Outcome Measures :
  1. Lesion Counts [ Time Frame: Baseline ]
    Lesion counts of the identified area of worst involvement will be done in a 5x5 cm area. All subsequent measurements will be done in the same 5x5 cm area.

  2. Lesion counts [ Time Frame: Change from baseline at week 1 ]
    Lesion counts in area of worst involvement in 5x5 cm area

  3. Lesion counts [ Time Frame: Change from baseline at week 2 ]
    Lesion count is performed in the worst area of involvement in 5x5 cm area

  4. Lesion counts [ Time Frame: Change from baseline at week 4 ]
    Lesion count in the area of worst involvement in 5x5 cm area

  5. Lesion count [ Time Frame: Change from baseline at week 8 ]
    Lesion counts in area of worst involvement in 5x5 cm area

  6. Lesion counts [ Time Frame: Change from baseline at week 12 ]
    Lesion count in area of worst involvement in 5x5 cm area

Secondary Outcome Measures :
  1. Quality of Life assessment [ Time Frame: Baseline ]
    Standardized quality of life (QOL) tool will be used to assess impact of symptoms on QOL.

  2. Quality of Life [ Time Frame: Change from baseline at week 1 ]
    Standardized QOL forms will be used

  3. Quality of Life [ Time Frame: Change from baseline at week 2 ]
    Standardized QOL form will be used

  4. Quality of Life [ Time Frame: Change from baseline at week 4 ]
    Standard QOL form will be used

  5. Quality of Life [ Time Frame: Change from baseline at week 8 ]
    Standard QOL form will be used

  6. Quality of Life [ Time Frame: Change from baseline at week 12 ]
    Standard QOL form will be used

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age and older at the time of study enrollment.
  • Started routine clinical, palliative, or experimental (off-label) treatment with erlotinib for solid tumors and have developed Grade 2 or higher skin toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.02.
  • Failed therapy with a two-week course of antibiotic (doxycycline 100 mg twice daily, or cephalexin 250 mg twice daily in patients allergic to doxycycline).
  • Willing and able to provide verbal and written informed consent
  • If reproductive potential, both males and females,must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to enrollment.

Exclusion Criteria:

  • Pregnant or breast-feeding females.
  • Known or suspected sensitivity to study medication.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or worse.
  • Treatment with a non-approved or investigational drug (with the exception of erlotinib used in an experimental setting) within 30 days prior to Day 1 of study treatment.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (e.g., infectious) illness.
  • Bilirubin greater than or equal to three times the upper limit of normal. Sexually active women of childbearing potential must use an effective method of birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01299220

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
OSI Pharmaceuticals
Principal Investigator: Larisa J Geskin, MD University of Pittsburgh

Responsible Party: University of Pittsburgh Identifier: NCT01299220     History of Changes
Other Study ID Numbers: PRO10020317
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by University of Pittsburgh:

Additional relevant MeSH terms:
Skin Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Keratolytic Agents
Dermatologic Agents