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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00718315
First received: July 16, 2008
Last updated: October 7, 2013
Last verified: October 2013
  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 3

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 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.

Resource links provided by NLM:


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 ]

Enrollment: 204
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po daily
Drug: fusidic acid [Verutex]
topical, daily for 30 days.
Experimental: 2 Drug: erlotinib [Tarceva]
150mg po daily
Drug: erythromycin [Eritex]
topical, daily for 30 days.
Experimental: 3 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Salvador, BA, Brazil, 41950-610
Salvador, BA, Brazil, 40170-110
Salvador, BA, Brazil, 40110-150
Fortaleza, CE, Brazil, 60190-800
Fortaleza, CE, Brazil, 60125-151
Taguatinga, DF, Brazil, 72115-700
Goiania, GO, Brazil, 74140-050
Belo horizonte, MG, Brazil, 30150-321
Belo Horizonte, MG, Brazil, 30150-281
Divinopolis, MG, Brazil, 35500-222
Recife, PE, Brazil, 50070-170
Curitiba, PR, Brazil, 80010030
Curitiba, PR, Brazil, 80810-050
Rio de Janeiro, RJ, Brazil, 22260-020
Rio De Janeiro, RJ, Brazil, 22290-160
Natal, RN, Brazil, 59040150
Ijui, RS, Brazil, 98700-000
Porto Alegre, RS, Brazil, 90430-090
Itajai, SC, Brazil, 88301-220
Ribeirao Preto, SP, Brazil, 14025-270
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 01406100
Sao Paulo, SP, Brazil, 05652-000
Sao Paulo, SP, Brazil, 01323-000
Sao Paulo, SP, Brazil, 01308-000
Sao Paulo, SP, Brazil, 04039-901
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: NCT00718315     History of Changes
Other Study ID Numbers: ML21450
Study First Received: July 16, 2008
Last Updated: October 7, 2013
Health Authority: Brazil: Ministry of Health

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
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Fusidic Acid
Erlotinib
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014