MATER Study: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
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Purpose
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 |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: erlotinib [Tarceva] Drug: metronidazole actavis 1% topical cream |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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). ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Completion Date: | March 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: erlotinib [Tarceva]
150mg po daily
Drug: metronidazole actavis 1% topical cream
Twice daily for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients, >=18 years of age;
- non-small cell lung cancer;
- eligible to start treatment with Tarceva.
Exclusion Criteria:
- hypersensitivity to metronidazole.
Contacts and Locations| Sweden | |
| Goeteborg, Sweden, 41345 | |
| Lund, Sweden, 22185 | |
| Malmoe, Sweden, 20502 | |
| Stockholm, Sweden, S-14186 | |
| Umea, Sweden, S-901 85 | |
| Vaxjo, Sweden, 35185 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00642473 History of Changes |
| Other Study ID Numbers: | ML21308, 2007-002895-32 |
| Study First Received: | March 19, 2008 |
| Last Updated: | June 16, 2009 |
| Health Authority: | Sweden: Central Ethics Committee, Stockholm |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Metronidazole |
Erlotinib Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013