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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer

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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

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