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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00531934
First received: September 18, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
 Drug: erlotinib [Tarceva]
Drug: Doxycline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of skin rash [ Time Frame: First 4 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate, rate of disease control, PFS, 1 year survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Specific skin toxicity assessment, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po daily
Drug: Doxycline
100mg po daily
Active Comparator: 2 Drug: erlotinib [Tarceva]
150mg po daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531934

Locations
France
Antibes, France, 06600
Bordeaux, France, 33300
Bordeaux, France, 33076
Brest, France, 29200
Caen, France, 14076
Chalon Sur Saone, France, 71100
Chartres, France, 28018
Draguignan, France, 83007
GAP, France, 05000
Gleize, France, 69400
Limoges, France, 87042
Metz, France, 57038
Nimes, France, 30900
Paris, France, 75674
Paris, France, 75116
Paris, France, 75679
Perigueux, France, 24000
Perpignan, France, 66000
Pierre Benite, France, 69310
Pontoise, France, 95300
Rennes, France, 35033
Rouen, France, 76000
Tours, France, 37044
Vannes, France, 56017
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00531934     History of Changes
Other Study ID Numbers: ML20829
Study First Received: September 18, 2007
Last Updated: May 23, 2013
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013