- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00642473
A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash (MATER)
April 14, 2016 updated by: Hoffmann-La Roche
A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Goeteborg, Sweden, 41345
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Lund, Sweden, 22185
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Malmoe, Sweden, 20502
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Stockholm, Sweden, S-14186
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Umea, Sweden, S-901 85
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Vaxjo, Sweden, 35185
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non-small cell lung cancer
- eligible to start treatment with erlotinib
Exclusion Criteria:
- hypersensitivity to metronidazole
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Other Names:
Metronidazole actavis 1% topical cream will be applied on 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).
|
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).
|
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Other Names:
Metronidazole actavis 1% topical cream will be applied on 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
Time Frame: After 2 weeks of metronidazole treatment
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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.
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After 2 weeks of metronidazole treatment
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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.
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After 4 weeks of metronidazole treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 19, 2008
First Submitted That Met QC Criteria
March 19, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
May 23, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Protein Kinase Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Erlotinib Hydrochloride
- Metronidazole
Other Study ID Numbers
- ML21308
- 2007-002895-32 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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