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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00531934

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 II

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:

MedlinePlus related topics: Cancer Lung Cancer Rashes

Drug Information available for: Erlotinib hydrochloride Erlotinib

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 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, 33076

Bordeaux, France, 33300

Brest, France, 29200

Caen, France, 14076

Chalon Sur Saone, France, 71100

Chartres, France, 28018

Draguignan, France, 83007

GAP, France, 05007

Gleize, France, 69400

Limoges, France, 87042

Metz, France, 57038

Nimes, France, 30900

Paris, France, 75674

Paris, France, 75679

Paris, France, 75116

Perigueux, France, 24000

Perpignan, France, 66012

Pierre Benite, France, 69495

Pontoise, France, 95300

Rennes, France, 35033

Rouen, France, 76031

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:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00531934 History of Changes
Other Study ID Numbers:	ML20829
Study First Received:	September 18, 2007
Last Updated:	May 18, 2011
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 February 12, 2012