Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: erlotinib [Tarceva]
  • 150mg po daily
• Drug: Doxycline
  • 100mg po daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Incidence of skin rash
  • Time Frame: First 4 months of treatment
    Safety Issue?: Yes

Secondary Measures

• Response rate, rate of disease control, PFS, 1 year survival.
  • Time Frame: Event driven
    Safety Issue?: No
• Specific skin toxicity assessment, AEs, laboratory parameters.
  • Time Frame: Throughout study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Overall Contact: Please reference Study ID Number: RLI_ML20829 973-235-5000 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00531934

Study ID Number: ML20829

ClinicalTrials.gov Identifier: NCT00531934

Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)