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

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ClinicalTrials.gov Identifier: NCT00642473
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Erlotinib Drug: Metronidazole Actavis Other: Non-active Moisturizing Cream Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2 [ Time Frame: After 2 weeks of metronidazole treatment ]
    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.

  2. Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4 [ Time Frame: After 4 weeks of metronidazole treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642473


Locations
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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
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642473    
Other Study ID Numbers: ML21308
2007-002895-32 ( EudraCT Number )
First Posted: March 25, 2008    Key Record Dates
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Metronidazole
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents