A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
MATER
A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash
2 other identifiers
interventional
34
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
May 23, 2016
CompletedMay 23, 2016
April 1, 2016
1.1 years
March 19, 2008
March 9, 2016
April 14, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
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.
After 2 weeks of metronidazole treatment
Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
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.
After 4 weeks of metronidazole treatment
Study Arms (2)
Prevention (Erlotinib + Metronidazole Actavis)
EXPERIMENTALParticipants 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).
Treatment (Erlotinib + Metronidazole Actavis)
EXPERIMENTALParticipants 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).
Interventions
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
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).
Eligibility Criteria
You may qualify if:
- non-small cell lung cancer
- eligible to start treatment with erlotinib
You may not qualify if:
- hypersensitivity to metronidazole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Gothenburg, 41345, Sweden
Unknown Facility
Lund, 22185, Sweden
Unknown Facility
Malmo, 20502, Sweden
Unknown Facility
Stockholm, S-14186, Sweden
Unknown Facility
Umeå, S-901 85, Sweden
Unknown Facility
Vaxjo, 35185, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 23, 2016
Results First Posted
May 23, 2016
Record last verified: 2016-04