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

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.

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: erlotinib [Tarceva]; Drug: fusidic acid [Verutex]; Drug: erythromycin [Eritex]; Drug: Fisiogel

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil, 40110-150
    • Salvador, BA, Brazil, 40170-110
    • Salvador, BA, Brazil, 41950-610
  • CE
    • Fortaleza, CE, Brazil, 60125-151
    • Fortaleza, CE, Brazil, 60190-800
  • DF
    • Taguatinga, DF, Brazil, 72115-700
  • GO
    • Goiania, GO, Brazil, 74140-050
  • MG
    • Belo Horizonte, MG, Brazil, 30150-281
    • Belo horizonte, MG, Brazil, 30150-321
    • Divinopolis, MG, Brazil, 35500-222
  • PE
    • Recife, PE, Brazil, 50070-170
  • PR
    • Curitiba, PR, Brazil, 80010030
    • Curitiba, PR, Brazil, 80810-050
  • RJ
    • Rio De Janeiro, RJ, Brazil, 22290-160
    • Rio de Janeiro, RJ, Brazil, 22260-020
  • RN
    • Natal, RN, Brazil, 59040150
  • RS
    • Ijui, RS, Brazil, 98700-000
    • Porto Alegre, RS, Brazil, 90430-090
  • SC
    • Itajai, SC, Brazil, 88301-220
  • SP
    • Ribeirao Preto, SP, Brazil, 14025-270
    • Sao Paulo, SP, Brazil, 01221-020
    • Sao Paulo, SP, Brazil, 05652-000
    • Sao Paulo, SP, Brazil, 01308-000
    • Sao Paulo, SP, Brazil, 01323-000
    • Sao Paulo, SP, Brazil, 01406100
    • Sao Paulo, SP, Brazil, 04039-901

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Develop Skin Rash	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").	30 Days
Percentage of Participants With Skin Rash Stratified by Severity Grade	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	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Appearance of Skin Rash	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	Days 0, 15, and 30
Percentage of Participants With Erythema	Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries	Days 0, 15, and 30
Percentage of Participants With Pruritus	Pruritus is defined as intense localized itching	Days 0, 15, and 30
Percentage of Participants With Pain	Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli	Days 0, 15, and 30
Percentage of Participants With Erythema Stratified by Severity Grade	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.	30 Days
Percentage of Participants With Pruritus Stratified by Severity Grade	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.	30 Days
Percentage of Participants With Pain Stratified by Severity Grade	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.	30 Days

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (ESTIMATE): July 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 9, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Kinase Inhibitors; Protein Synthesis Inhibitors; Erlotinib Hydrochloride; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Fusidic Acid
• Other Study ID Numbers: ML21450