Phase 2 N=34 Treatment

A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash

Non-Squamous Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00642473 ↗

Enrolled (actual)

Serious AEs

23.5%

Results posted

May 2016

Primary outcome: Primary: Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 — 11; 22; 0; 33 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib (Drug); Metronidazole Actavis (Drug); Non-active Moisturizing Cream (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2	11; 22; 0; 33; 56; 56	—
PRIMARY Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4	13; 25; 0; 25; 75; 63	—

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.

Eligibility Criteria

Inclusion Criteria

non-small cell lung cancer
eligible to start treatment with erlotinib

Exclusion Criteria

hypersensitivity to metronidazole

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00642473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.