A Phase 2 interventional study of Erlotinib and Metronidazole Actavis in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 6 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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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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 · Drug: Metronidazole Actavis · Other: Non-active Moisturizing Cream
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 · Drug: Metronidazole Actavis · Other: Non-active Moisturizing Cream
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Also known as: Tarceva
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).
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.
Time frame: 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.
Time frame: After 4 weeks of metronidazole treatment
| Milestone | Prevention (Erlotinib + Metronidazole Actavis) | Treatment (Erlotinib + Metronidazole Actavis) |
|---|---|---|
| Started | 18 | 16 |
| Completed | 14 | 5 |
| Not completed | 4 | 11 |
| Withdrew: Withdrawal by subject | 0 | 5 |
| Withdrew: Progression or death | 2 | 4 |
| Withdrew: Other | 2 | 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.
| percentage of participants | Left Side - Prevention (Erlotinib + Standard Procedures) | Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Left Side - Treatment (Erlotinib + Standard Procedures) | Right Side - Treatment (Erlotinib + Metronidazole Actavis) |
|---|---|---|---|---|
| Facial Rash: Grade 0 (n=9,9,6,6) | 11 | 22 | 0 | 33 |
| Chest Rash: Grade 0 (n=9,9,6,6) | 56 | 56 | 33 | 50 |
| Facial Rash: Grade 1 (n=9,9,6,6) | 33 | 22 | 50 | 33 |
| Chest Rash: Grade 1 (n=9,9,6,6) | 33 | 33 | 17 | 17 |
| Facial Rash: Grade 2 (n=9,9,6,6) | 22 | 33 | 33 | 17 |
| Chest Rash: Grade 2 (n=9,9,6,6) | 11 | 11 | 33 | 17 |
| Facial Rash: Grade 3 (n=9,9,6,6) | 33 | 22 | 17 | 17 |
| Chest Rash: Grade 3 (n=9,9,6,6) | 0 | 0 | 17 | 17 |
| Facial Rash: Grade 4 (n=9,9,6,6) | 0 | 0 | 0 | 0 |
| Chest Rash: Grade 4 (n=9,9,6,6) | 0 | 0 | 0 | 0 |
| Facial Rash: Grade 5 (n=9,9,6,6) | 0 | 0 | 0 | 0 |
| Chest Rash: Grade 5 (n=9,9,6,6) | 0 | 0 | 0 | 0 |
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.
| percentage of participants | Left Side - Prevention (Erlotinib + Standard Procedures) | Right Side - Prevention (Erlotinib + Metronidazole Actavis) | Left Side - Treatment (Erlotinib + Standard Procedures) | Right Side - Treatment (Erlotinib + Metronidazole Actavis) |
|---|---|---|---|---|
| Facial Rash: Grade 0 (n=8,8,4,4) | 13 | 25 | 0 | 25 |
| Chest Rash: Grade 0 (n=8,8,4,4) | 75 | 63 | 25 | 50 |
| Facial Rash: Grade 1 (n=8,8,4,4) | 63 | 50 | 50 | 50 |
| Chest Rash: Grade 1 (n=8,8,4,4) | 0 | 13 | 25 | 25 |
| Facial Rash: Grade 2 (n=8,8,4,4) | 13 | 25 | 25 | 50 |
| Chest Rash: Grade 2 (n=8,8,4,4) | 13 | 13 | 25 | 25 |
| Facial Rash: Grade 3 (n=8,8,4,4) | 0 | 0 | 0 | 0 |
| Chest Rash: Grade 3 (n=8,8,4,4) | 0 | 13 | 0 | 0 |
| Facial Rash: Grade 4 (n=8,8,4,4) | 13 | 0 | 0 | 0 |
| Chest Rash: Grade 4 (n=8,8,4,4) | 13 | 0 | 0 | 0 |
| Facial Rash: Grade 5 (n=8,8,4,4) | 0 | 0 | 0 | 0 |
| Chest Rash: Grade 5 (n=8,8,4,4) | 0 | 0 | 0 | 0 |
Collected over Baseline to Week 4. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prevention (Erlotinib + Metronidazole Actavis) | — | 3/18 (16.7%) | 6/18 (33.3%) |
| Treatment (Erlotinib + Metronidazole Actavis) | — | 5/16 (31.3%) | 1/16 (6.3%) |
| Event | Prevention (Erlotinib + Metronidazole Actavis) | Treatment (Erlotinib + Metronidazole Actavis) |
|---|---|---|
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/18 | 3/16 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/18 | 1/16 |
| FallingGeneral disorders | 0/18 | 1/16 |
| DiarrheaGastrointestinal disorders | 1/18 | 0/16 |
| Event | Prevention (Erlotinib + Metronidazole Actavis) | Treatment (Erlotinib + Metronidazole Actavis) |
|---|---|---|
| DiarrheaGastrointestinal disorders | 4/18 | 1/16 |
| AphthaeGastrointestinal disorders | 1/18 | 0/16 |
| PainGastrointestinal disorders | 1/18 | 0/16 |
All enrolled participants
| Age, Continuous(years) | Prevention (Erlotinib + Metronidazole Actavis) | Treatment (Erlotinib + Metronidazole Actavis) | Total |
|---|---|---|---|
| Mean | 68 ± 10.8 | 70 ± 13.1 | 69 ± 11.8 |
| Sex: Female, Male(Participants) | Prevention (Erlotinib + Metronidazole Actavis) | Treatment (Erlotinib + Metronidazole Actavis) | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 7 | 4 | 11 |
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Carcinoma, Non-Small-Cell Lung→
Hoffmann-La Roche