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

• Status: Withdrawn
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: OSI Pharmaceuticals
• Treatments: Acitretin; Erlotinib Hydrochloride

Criteria

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