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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00642473 |
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.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: erlotinib [Tarceva] Drug: metronidazole actavis 1% topical cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official 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 |
Enrollment: | 34 |
Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: erlotinib [Tarceva]
150mg po daily
Drug: metronidazole actavis 1% topical cream
Twice daily for 4 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
MALMOE, Sweden, 20502 | |
GOETEBORG, Sweden, 41345 | |
LUND, Sweden, 22185 | |
VAXJO, Sweden, 35185 | |
UMEA, Sweden, S-901 85 | |
STOCKHOLM, Sweden, S-14186 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21308, 2007-002895-32 |
Study First Received: | March 19, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00642473 History of Changes |
Health Authority: | Sweden: Central Ethics Committee, Stockholm |
Thoracic Neoplasms Erlotinib Metronidazole Protein Kinase Inhibitors Carcinoma Exanthema Respiratory Tract Diseases |
Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Erlotinib Anti-Infective Agents Respiratory Tract Neoplasms Metronidazole Antiprotozoal Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Antiparasitic Agents Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |