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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642473
• Other study ID #: ML21308
• Secondary ID: 2007-002895-32
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: December 1, 2015
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethics Committee, Stockholm
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• non-small cell lung cancer;

• eligible to start treatment with Tarceva.

Exclusion Criteria:

• hypersensitivity to metronidazole.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• erlotinib [Tarceva]
150mg po daily
• metronidazole actavis 1% topical cream
Twice daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and intensity of Tarceva-associated rash (CTC AE v3.0)		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).	No
Secondary	Adverse events		Throughout study	No