A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00718315

Purpose

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: erlotinib [Tarceva] Drug: fusidic acid [Verutex] Drug: erythromycin [Eritex] Drug: Fisiogel	Phase III

MedlinePlus related topics: Cancer Lung Cancer Rashes

Drug Information available for: Erythromycin Gluceptate Erythromycin Erlotinib hydrochloride Erlotinib Erythromycin stearate Fusidate Sodium Erythromycin ethylsuccinate Erythromycin estolate Fusidic acid

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 Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients who develop skin rash [ Time Frame: Day 27-36 of Tarceva treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of treatment discontinuation due to skin rash [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Time to appearance of skin rash [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	312
Estimated Study Completion Date:	November 2010

Arms	Assigned Interventions
1: Experimental	Drug: erlotinib [Tarceva] 150mg po daily Drug: fusidic acid [Verutex] topical, daily for 30 days.
2: Experimental	Drug: erlotinib [Tarceva] 150mg po daily Drug: erythromycin [Eritex] topical, daily for 30 days.
3: Experimental	Drug: erlotinib [Tarceva] 150mg po daily Drug: Fisiogel topical, daily for 30 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);
eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.

Exclusion Criteria:

presence of skin rash or other signs of skin toxicity;
treatment with any systemic or intranasal antibiotic within 7 days before randomization;
treatment with other topical formulation within 14 days before randomization;
other anticancer therapy in addition to Tarceva.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718315

Contacts

Contact: Please reference Study ID Number: ML21450	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Brazil
	Not yet recruiting
SAO PAULO, Brazil, 01308-000
	Recruiting
BELO HORIZONTE, Brazil, 30150-320
	Not yet recruiting
SAO PAULO, Brazil, 01401-901
	Recruiting
RIBEIRÃO PRETO, Brazil, 14025-430
	Not yet recruiting
SALVADOR, Brazil, 40170-070
	Recruiting
GOIANIA, Brazil, 74075-040
	Not yet recruiting
CURITIBA, Brazil, 80730-180
	Recruiting
IJUÍ, Brazil, 98700-000
	Not yet recruiting
FORTALEZA, Brazil, 60125-151
	Not yet recruiting
Porto Alegre, Brazil, 90430-090
	Recruiting
SAO PAULO, Brazil, 01221-020
	Recruiting
RIO DE JANEIRO, Brazil, 22260-020
	Not yet recruiting
RIO DE JANEIRO, Brazil, 22631-004
	Recruiting
SAO PAULO, Brazil, 04039-901
	Not yet recruiting
SÃO PAULO, Brazil, 01323-000
	Not yet recruiting
ITAJAÍ, Brazil, 88301-220
	Not yet recruiting
SAO PAULO, Brazil, 05651-901
	Not yet recruiting
TAGUATINGA, Brazil, 72115-700
	Not yet recruiting
NATAL, Brazil, 59062-000
	Not yet recruiting
SALVADOR, Brazil, 40110-150
	Not yet recruiting
RECIFE, Brazil, 50070-170
	Not yet recruiting
FORTALEZA, Brazil, 60190-800
	Not yet recruiting
CURITIBA, Brazil, 80010-030
	Recruiting
BELO HORIZONTE, Brazil, 30150-281
	Not yet recruiting
SAO PAULO, Brazil, 01227-200
	Not yet recruiting
CURITIBA, Brazil, 80810-050
	Recruiting
DIVINÓPOLIS, Brazil, 35500-222
	Not yet recruiting
SALVADOR, Brazil, 41825-010

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21450
Study First Received:	July 16, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00718315 History of Changes
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Erythromycin stearate
Fusidic Acid
Erythromycin Ethylsuccinate
Erythromycin
Protein Kinase Inhibitors
Carcinoma
Anti-Bacterial Agents

Exanthema
Respiratory Tract Diseases
Erythromycin Estolate
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Erythromycin stearate
Thoracic Neoplasms
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Protein Kinase Inhibitors
Anti-Bacterial Agents
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Erlotinib
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Fusidic Acid
Gastrointestinal Agents
Enzyme Inhibitors
Erythromycin
Pharmacologic Actions
Carcinoma
Protein Synthesis Inhibitors
Neoplasms
Erythromycin Estolate
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009