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NCT Number: NCT00642473

A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non-small cell lung cancer
  • eligible to start treatment with erlotinib

Exclusion criteria

  • hypersensitivity to metronidazole

Treatment and study plan

Erlotinib

Drug

Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.

Other names: Tarceva

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).

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: MATER

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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