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

Sponsored by:	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

MedlinePlus related topics: Cancer Lung Cancer Rashes

Drug Information available for: Erlotinib Erlotinib hydrochloride Doxycycline Doxycycline calcium Doxycycline hyclate

U.S. FDA Resources

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

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

Contacts

Contact: Please reference Study ID Number: ML20829	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Recruiting
PARIS, France, 75674
	Recruiting
ANTIBES, France, 06600
	Recruiting
PONTOISE, France, 95303
	Recruiting
CAEN, France, 14076
	Recruiting
BORDEAUX, France, 33300
	Recruiting
DRAGUIGNAN, France, 83007
	Recruiting
RENNES, France, 35033
	Recruiting
PERIGUEUX, France, 24000
	Recruiting
METZ, France, 57038
	Recruiting
BREST, France, 29200
	Recruiting
PIERRE BENITE, France, 69310
	Recruiting
CHALON SUR SAONE, France, 71100
	Not yet recruiting
LEVALLOIS PERRET, France, 92300
	Recruiting
VANNES, France, 56017
	Recruiting
CHARTRES, France, 28018
	Recruiting
NIMES, France, 30907
	Recruiting
ROUEN, France, 76000
	Recruiting
BORDEAUX, France, 33076
	Recruiting
PERPIGNAN, France, 66000
	Recruiting
PARIS, France, 75116
	Recruiting
PARIS, France, 75014
	Recruiting
GAP, France, 05000
	Recruiting
TOURS, France, 37044
	Recruiting
GLEIZE, France, 69400
	Recruiting
LIMOGES, France, 87042

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20829
Study First Received:	September 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00531934
Health Authority:	France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Exanthema
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Doxycycline
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009