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

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: April 14, 2016
Last verified: April 2016
  Purpose
This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants 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 (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants 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 less than (<) 3 months, and the target sample size is <100 individuals.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Erlotinib
Drug: Metronidazole Actavis
Other: Non-active Moisturizing Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 [ Time Frame: After 2 weeks of metronidazole treatment ] [ Designated as safety issue: No ]
    Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.

  • Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 [ Time Frame: After 4 weeks of metronidazole treatment ] [ Designated as safety issue: No ]
    Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.


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: Prevention (Erlotinib + Metronidazole Actavis)
Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Drug: Erlotinib
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Other Name: Tarceva
Drug: Metronidazole Actavis
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
Other: Non-active Moisturizing Cream
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Experimental: Treatment (Erlotinib + Metronidazole Actavis)
Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
Drug: Erlotinib
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Other Name: Tarceva
Drug: Metronidazole Actavis
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
Other: Non-active Moisturizing Cream
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-small cell lung cancer
  • eligible to start treatment with erlotinib

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

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
Results First Received: March 9, 2016
Last Updated: April 14, 2016
Health Authority: Sweden: Central Ethics Committee, Stockholm

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Emollients
Erlotinib Hydrochloride
Metronidazole
Anti-Infective Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016