Phase 3
N=201
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00718315 ↗Enrolled (actual)
201
Serious AEs
22.0%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants Who Develop Skin Rash — 60.0; 69.2; 73.1 percentage of participants — p=0.481
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- erlotinib [Tarceva] (Drug); fusidic acid [Verutex] (Drug); erythromycin [Eritex] (Drug); Fisiogel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Develop Skin Rash |
60.0; 69.2; 73.1 | 0.481 |
| PRIMARY Percentage of Participants With Skin Rash Stratified by Severity Grade |
29.8; 25.0; 18.3; 21.1; 18.3; 43.3 | — |
| SECONDARY Time to Appearance of Skin Rash |
16.0; 15.0; 15.0 | 0.095 |
| SECONDARY Percentage of Participants With Erythema |
56.7; 56.7; 43.3 | 0.199 |
| SECONDARY Percentage of Participants With Pruritus |
36.1; 47.6; 29.5 | 0.108 |
| SECONDARY Percentage of Participants With Pain |
16.4; 25.4; 13.4 | 0.179 |
| SECONDARY Percentage of Participants With Erythema Stratified by Severity Grade |
37.7; 39.7; 52.5; 39.3; 36.5; 39.3 | 0.066 |
| SECONDARY Percentage of Participants With Pruritus Stratified by Severity Grade |
63.9; 52.4; 70.5; 19.7; 31.7; 24.6 | 0.087 |
| SECONDARY Percentage of Participants With Pain Stratified by Severity Grade |
82.0; 73.0; 85.2; 11.5; 22.2; 6.6 | 0.308 |
Summary
This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);
- eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.
Exclusion Criteria
- presence of skin rash or other signs of skin toxicity;
- treatment with any systemic or intranasal antibiotic within 7 days before randomization;
- treatment with other topical formulation within 14 days before randomization;
- other anticancer therapy in addition to Tarceva.
Data sourced from ClinicalTrials.gov (NCT00718315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.