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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642473

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Rashes

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Erlotinib hydrochloride Erlotinib Metronidazole

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642473

Locations

Sweden

Goeteborg, Sweden, 41345

Lund, Sweden, 22185

Malmoe, Sweden, 20502

Stockholm, Sweden, S-14186

Umea, Sweden, S-901 85

Vaxjo, Sweden, 35185

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

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 February 12, 2012