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

Sponsor
Hoffmann-La Roche
Study ID
NCT00642473
Phase
PHASE2
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
  • Metronidazole Actavis — DRUG
    Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
  • Non-active Moisturizing Cream — OTHER
    Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).

Study Details

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.

Key Dates

First listed
Mar 25, 2008
Start date
Feb 29, 2008
Status verified
Apr 2016
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

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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