Trial Information
A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
Inclusion Criteria:
- adult patients, 18-75 years of age;
- confirmed non-small cell lung cancer;
- failure after first line chemotherapy for advanced disease, and scheduled for second
line therapy with Tarceva.
Exclusion Criteria:
- rash of any etiology at study entry;
- history of significant heart disease;
- any other malignancies (other than adequately treated squamous cell skin cancer, or
in situ cancer of the cervix);
- history of allergic reactions to tetracyclines.
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:
Incidence of skin rash
Outcome Time Frame:
First 4 months of treatment
Safety Issue:
Yes
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)
Study ID:
ML20829
NCT ID:
NCT00531934
Start Date:
October 2007
Completion Date:
August 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms