A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%)
topical cream in the prevention and treatment of rash associated with Tarceva treatment, in
participants with non-small cell lung cancer. The first cohort of participants enrolled in
the study will be treated twice daily with metronidazole cream on the right side of the face
and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily).
The corresponding body parts on the left side will be treated according to local standard
procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated
participants will only receive twice daily treatment with metronidazole cream if and when
they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The
anticipated time on metronidazole treatment is less than (<) 3 months, and the target sample
size is <100 individuals.