Trial information
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Status: Not yet recruiting
Protocol number: ML21450
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the use of the dermatological creams Verutex, Eritex and Fisiogel in the management of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer.
Brief 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. Target sample size is
312.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Percentage of patients who develop skin rash Time frame: Day 27-36 of Tarceva treatment
Key secondary outcomes: 1. Rate of treatment discontinuation due to skin rash Time frame: Throughout study
2. Time to appearance of skin rash Time frame: Throughout study
3. AEs Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2008
Trial registration date: 07/15/2008
Date last updated: 11/21/2008
Link to trial result
This trial will be conducted at the following locations:
Brazil
- Belo Horizonte
- Curitiba
- Divinópolis
- Fortaleza
- Goiania
- Ijuí
- Itajaí
- Natal
- Porto Alegre Rs
- Recife
- Ribeirão Preto
- Rio De Janeiro
- Salvador
- Sao Paulo
- São Paulo
- Taguatinga
