Clinical Trial Protocol Registry
MATER Study: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
- Protocol number:
- Hoffmann-La Roche
- Company division:
- Official Scientific Title:
- MATER An open label study to assess the effect of metronidazole actavis 1% topical cream in the prevention and treatment of Tarceva-associated rash in patients with non-small cell lung cancer
- Brief summary:
- This study will evaluate the efficacy and safety of metronidazole actavis 1% topical cream in the prevention and treatment of rash associated with Tarceva treatment, in patients with non-small cell lung cancer. The first cohort of patients 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 (150mg po daily). The corresponding body parts on the left side are treated according to local standard procedures (ie with non-active moisturising cream). The second cohort of Tarceva-treated patients 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 <3 months, and the target sample size is <100 individuals. Target sample size is 34.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Single group; Safety/efficacy study
- Non-Small Cell Lung Cancer
- Intervention type:
- Intervention name:
- erlotinib [Tarceva]
- Primary outcome:
- Frequency and intensity of Tarceva-associated rash (CTC AE v3.0) Time frame: At baseline, and after 2 and 4 weeks of metronidazole treatment (prevention cohort); at baseline, at appearance of rash, and after 2 and 4 weeks of metronidazole treatment (treatment cohort).
- Key secondary outcomes:
- Adverse events Time frame: Throughout study
- Inclusion criteria:
- adult patients, >=18 years of age;
- non-small cell lung cancer;
- eligible to start treatment with Tarceva.
- Exclusion criteria:
- hypersensitivity to metronidazole.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- February, 2008
- Trial registration date:
- Date last updated:
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