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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Unnamed facility
Gothenburg, Sweden
Unnamed facility
Lund, Sweden
Unnamed facility
Malmö, Sweden
Unnamed facility
Stockholm, Sweden
Unnamed facility
Umeå, Sweden
Unnamed facility
Vaxjo, Sweden
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.
Time frame: After 2 weeks of metronidazole treatment
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.
Time frame: After 4 weeks of metronidazole treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.