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

Skin Rash Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01299220
• Other study ID #: PRO10020317
• Status: Withdrawn
• Phase: Phase 4
• First received: February 15, 2011
• Last updated: January 14, 2013
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exanthema
• Skin Rash

Intervention

Drug:
• Acitretin
Acitretin 10 mg by mouth daily

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Lesion counts	Lesion counts in area of worst involvement in 5x5 cm area	Change from baseline at week 1	No
Primary	Lesion counts	Lesion count is performed in the worst area of involvement in 5x5 cm area	Change from baseline at week 2	No
Primary	Lesion counts	Lesion count in the area of worst involvement in 5x5 cm area	Change from baseline at week 4	No
Primary	Lesion count	Lesion counts in area of worst involvement in 5x5 cm area	Change from baseline at week 8	No
Primary	Lesion counts	Lesion count in area of worst involvement in 5x5 cm area	Change from baseline at week 12	No
Secondary	Quality of Life assessment	Standardized quality of life (QOL) tool will be used to assess impact of symptoms on QOL.	Baseline	No
Secondary	Quality of Life	Standardized QOL forms will be used	Change from baseline at week 1	No
Secondary	Quality of Life	Standardized QOL form will be used	Change from baseline at week 2	No
Secondary	Quality of Life	Standard QOL form will be used	Change from baseline at week 4	No
Secondary	Quality of Life	Standard QOL form will be used	Change from baseline at week 8	No
Secondary	Quality of Life	Standard QOL form will be used	Change from baseline at week 12	No