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

Non-Small Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718315
• Other study ID #: ML21450
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2008
• Last updated: January 9, 2015
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• erlotinib [Tarceva]
150mg po daily
• fusidic acid [Verutex]
topical, daily for 30 days.
• erythromycin [Eritex]
topical, daily for 30 days.
• Fisiogel
topical, daily for 30 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants With Pruritus	Pruritus is defined as intense localized itching	Days 0, 15, and 30	No
Secondary	Percentage of Participants With Pain	Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli	Days 0, 15, and 30	No
Secondary	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	No
Secondary	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	No
Secondary	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	No