A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.

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

This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.

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.