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

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: erlotinib [Tarceva]; Drug: erythromycin [Eritex]; Drug: Fisiogel; Drug: fusidic acid [Verutex]

• Registration Number: NCT00718315
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Study Start: 2009-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-01
• Results First Submitted: 2015-01-09
• Results First Submitted QC: 2015-01-09
• Last Update Submitted: 2015-01-09
• Results First Posted: 2015-01-15
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	erythromycin [Eritex]	-
3	Fisiogel	-
1	erlotinib [Tarceva]	-
3	erlotinib [Tarceva]	-
1	fusidic acid [Verutex]	-
2	erlotinib [Tarceva]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Skin Rash Stratified by Severity Grade	30 Days	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
Percentage of Participants Who Develop Skin Rash	30 Days	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").

Secondary Outcome Measures

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