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.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients who develop skin rash
Outcome Time Frame:
Day 27-36 of Tarceva treatment
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Brazil: Ministry of Health
Study ID:
ML21450
NCT ID:
NCT00718315
Start Date:
April 2009
Completion Date:
June 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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