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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642473
First received: March 19, 2008
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will evaluate the efficacy and safety of metronidazole actavis 1% top ical cream in the prevention and treatment of rash associated with Tarceva treat ment, 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 th e 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 d aily treatment with metronidazole cream if and when they develop rash.In both co horts, 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 individ uals.


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: 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:


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 Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: July 7, 2014
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 July 22, 2014