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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Pilot Study of Acitretin for Treatment of Erlotinib-induced Skin Rash

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.

Detailed Summary:

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.


Sponsor: University of Pittsburgh

Current Primary Outcome:

  • 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.
  • Lesion counts [ Time Frame: Change from baseline at week 1 ]
    Lesion counts in area of worst involvement in 5x5 cm area
  • Lesion counts [ Time Frame: Change from baseline at week 2 ]
    Lesion count is performed in the worst area of involvement in 5x5 cm area
  • Lesion counts [ Time Frame: Change from baseline at week 4 ]
    Lesion count in the area of worst involvement in 5x5 cm area
  • Lesion count [ Time Frame: Change from baseline at week 8 ]
    Lesion counts in area of worst involvement in 5x5 cm area
  • Lesion counts [ Time Frame: Change from baseline at week 12 ]
    Lesion count in area of worst involvement in 5x5 cm area


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: February 15, 2011
Date Started: November 2010
Date Completion: September 2011
Last Updated: January 14, 2013
Last Verified: January 2013