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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: erlotinib [Tarceva]
* Drug: fusidic acid [Verutex]
* Drug: erythromycin [Eritex]
* Drug: Fisiogel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: erlotinib [Tarceva]<br>* 150mg po daily<br>Drug: fusidic acid [Verutex]<br>* topical, daily for 30 days.<br>|
| Experimental: 2<br> | Drug: erlotinib [Tarceva]<br>* 150mg po daily<br>Drug: erythromycin [Eritex]<br>* topical, daily for 30 days.<br>|
| Experimental: 3<br> | Drug: erlotinib [Tarceva]<br>* 150mg po daily<br>Drug: Fisiogel<br>* topical, daily for 30 days<br>|

What is the study measuring?
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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 |