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:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	120
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2010

Arms	Assigned Interventions
1: Experimental	Drug: erlotinib [Tarceva] 150mg po daily Drug: Doxycline 100mg po daily
2: Active Comparator	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

Paris, France, 75674

Antibes, France, 06600

Pontoise, France, 95303

Caen, France, 14076

Bordeaux, France, 33300

Draguignan, France, 83007

Rennes, France, 35033

Perigueux, France, 24000

Metz, France, 57038

Brest, France, 29200

Pierre Benite, France, 69310

Chalon Sur Saone, France, 71100

Gleize, France, 69400

Vannes, France, 56017

Chartres, France, 28018

Nimes, France, 30907

Rouen, France, 76000

Bordeaux, France, 33076

Perpignan, France, 66000

Paris, France, 75116

Paris, France, 75014

Gap, France, 05000

Tours, France, 37044

Limoges, France, 87042

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	ML20829
Study First Received:	September 18, 2007
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00531934 History of Changes
Health Authority:	France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010