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: January 9, 2015
Last verified: January 2015
  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 Participants Who Develop Skin Rash [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").

  • Percentage of Participants With Skin Rash Stratified by Severity Grade [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death


Secondary Outcome Measures:
  • Time to Appearance of Skin Rash [ Time Frame: Days 0, 15, and 30 ] [ Designated as safety issue: No ]
    Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE

  • Percentage of Participants With Erythema [ Time Frame: Days 0, 15, and 30 ] [ Designated as safety issue: No ]
    Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries

  • Percentage of Participants With Pruritus [ Time Frame: Days 0, 15, and 30 ] [ Designated as safety issue: No ]
    Pruritus is defined as intense localized itching

  • Percentage of Participants With Pain [ Time Frame: Days 0, 15, and 30 ] [ Designated as safety issue: No ]
    Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli

  • Percentage of Participants With Erythema Stratified by Severity Grade [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.

  • Percentage of Participants With Pruritus Stratified by Severity Grade [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.

  • Percentage of Participants With Pain Stratified by Severity Grade [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.


Enrollment: 201
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, 40110-150
Salvador, BA, Brazil, 40170-110
Salvador, BA, Brazil, 41950-610
Fortaleza, CE, Brazil, 60125-151
Fortaleza, CE, Brazil, 60190-800
Taguatinga, DF, Brazil, 72115-700
Goiania, GO, Brazil, 74140-050
Belo Horizonte, MG, Brazil, 30150-281
Belo horizonte, MG, Brazil, 30150-321
Divinopolis, MG, Brazil, 35500-222
Recife, PE, Brazil, 50070-170
Curitiba, PR, Brazil, 80010030
Curitiba, PR, Brazil, 80810-050
Rio De Janeiro, RJ, Brazil, 22290-160
Rio de Janeiro, RJ, Brazil, 22260-020
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, 01308-000
Sao Paulo, SP, Brazil, 01323-000
Sao Paulo, SP, Brazil, 01406100
Sao Paulo, SP, Brazil, 04039-901
Sao Paulo, SP, Brazil, 05652-000
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
Results First Received: January 9, 2015
Last Updated: January 9, 2015
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 29, 2015