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

Verified by: Hoffmann-La Roche, May 2011
First Received: September 18, 2007 | Last Updated: May 18, 2011 | Phase: Phase 2 | Start Date: 
Overall Status: Completed | Estimated Enrollment: 147
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: August 2010

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Hoffmann-La Roche Industry

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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)

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