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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib
* Drug: Metronidazole Actavis
* Other: Non-active Moisturizing Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-small cell lung cancer eligible to start treatment with erlotinib Exclusion Criteria: hypersensitivity to metronidazole

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (Erlotinib + Metronidazole Actavis)<br>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<br>* Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.<br>* Other names: Tarceva;Drug: Metronidazole Actavis<br>* Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.<br>Other: Non-active Moisturizing Cream<br>* Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).<br>|
| Experimental: Treatment (Erlotinib + Metronidazole Actavis)<br>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<br>* Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.<br>* Other names: Tarceva;Drug: Metronidazole Actavis<br>* Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.<br>Other: Non-active Moisturizing Cream<br>* Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |