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.
1 other identifier
interventional
201
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
Started Apr 2009
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
January 15, 2015
CompletedJanuary 15, 2015
January 1, 2015
3.2 years
July 16, 2008
January 9, 2015
January 9, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Time to Appearance of Skin Rash
Days 0, 15, and 30
Percentage of Participants With Erythema
Days 0, 15, and 30
Percentage of Participants With Pruritus
Days 0, 15, and 30
Percentage of Participants With Pain
Days 0, 15, and 30
Percentage of Participants With Erythema Stratified by Severity Grade
30 Days
- +2 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Fortaleza, Ceará, 60125-151, Brazil
Unknown Facility
Fortaleza, Ceará, 60190-800, Brazil
Unknown Facility
Salvador, Estado de Bahia, 40110-150, Brazil
Unknown Facility
Salvador, Estado de Bahia, 40170-110, Brazil
Unknown Facility
Salvador, Estado de Bahia, 41950-610, Brazil
Unknown Facility
Taguatinga, Federal District, 72115-700, Brazil
Unknown Facility
Goiânia, Goiás, 74140-050, Brazil
Unknown Facility
Belo Horizonte, Minas Gerais, 30150-281, Brazil
Unknown Facility
Belo Horizonte, Minas Gerais, 30150-321, Brazil
Unknown Facility
Divinópolis, Minas Gerais, 35500-222, Brazil
Unknown Facility
Curitiba, Paraná, 80010030, Brazil
Unknown Facility
Curitiba, Paraná, 80810-050, Brazil
Unknown Facility
Recife, Pernambuco, 50070-170, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 22260-020, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 22290-160, Brazil
Unknown Facility
Natal, Rio Grande do Norte, 59040150, Brazil
Unknown Facility
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Unknown Facility
Itajaí, Santa Catarina, 88301-220, Brazil
Unknown Facility
Ribeirão Preto, São Paulo, 14025-270, Brazil
Unknown Facility
São Paulo, São Paulo, 01221-020, Brazil
Unknown Facility
São Paulo, São Paulo, 01308-000, Brazil
Unknown Facility
São Paulo, São Paulo, 01323-000, Brazil
Unknown Facility
São Paulo, São Paulo, 01406100, Brazil
Unknown Facility
São Paulo, São Paulo, 04039-901, Brazil
Unknown Facility
São Paulo, São Paulo, 05652-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
April 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 15, 2015
Results First Posted
January 15, 2015
Record last verified: 2015-01