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

Pilot Study of Acitretin for Treatment of Erlotinib-induced Skin Rash

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Rash
• Intervention / Treatment: Drug: Acitretin

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Counts	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.	Baseline
Lesion counts	Lesion counts in area of worst involvement in 5x5 cm area	Change from baseline at week 1
Lesion counts	Lesion count is performed in the worst area of involvement in 5x5 cm area	Change from baseline at week 2
Lesion counts	Lesion count in the area of worst involvement in 5x5 cm area	Change from baseline at week 4
Lesion count	Lesion counts in area of worst involvement in 5x5 cm area	Change from baseline at week 8
Lesion counts	Lesion count in area of worst involvement in 5x5 cm area	Change from baseline at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life assessment	Standardized quality of life (QOL) tool will be used to assess impact of symptoms on QOL.	Baseline
Quality of Life	Standardized QOL forms will be used	Change from baseline at week 1
Quality of Life	Standardized QOL form will be used	Change from baseline at week 2
Quality of Life	Standard QOL form will be used	Change from baseline at week 4
Quality of Life	Standard QOL form will be used	Change from baseline at week 8
Quality of Life	Standard QOL form will be used	Change from baseline at week 12

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: OSI Pharmaceuticals
• Investigators: Principal Investigator: Larisa J Geskin, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Erlotinib; Oncology; Dermatology; Rash; Acitretin
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema; Dermatologic Agents; Keratolytic Agents; Acitretin
• Other Study ID Numbers: PRO10020317