Clinical trial NCT00718315: A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Develop Skin Rash
timeFrame: 30 Days
measure: Percentage of Participants With Skin Rash Stratified by Severity Grade
timeFrame: 30 Days
Secondary outcomes:
measure: Time to Appearance of Skin Rash
timeFrame: Days 0, 15, and 30
measure: Percentage of Participants With Erythema
timeFrame: Days 0, 15, and 30
measure: Percentage of Participants With Pruritus
timeFrame: Days 0, 15, and 30
measure: Percentage of Participants With Pain
timeFrame: Days 0, 15, and 30
measure: Percentage of Participants With Erythema Stratified by Severity Grade
timeFrame: 30 Days
measure: Percentage of Participants With Pruritus Stratified by Severity Grade
timeFrame: 30 Days
measure: Percentage of Participants With Pain Stratified by Severity Grade
timeFrame: 30 Days
Other outcomes:
Locations:
city: Salvador
country: Brazil
state: BA
city: Salvador
country: Brazil
state: BA
city: Salvador
country: Brazil
state: BA
city: Fortaleza
country: Brazil
state: CE
city: Fortaleza
country: Brazil
state: CE
city: Taguatinga
country: Brazil
state: DF
city: Goiania
country: Brazil
state: GO
city: Belo Horizonte
country: Brazil
state: MG
city: Belo horizonte
country: Brazil
state: MG
city: Divinopolis
country: Brazil
state: MG
city: Recife
country: Brazil
state: PE
city: Curitiba
country: Brazil
state: PR
city: Curitiba
country: Brazil
state: PR
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio De Janeiro
country: Brazil
state: RJ
city: Natal
country: Brazil
state: RN
city: Ijui
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Itajai
country: Brazil
state: SC
city: Ribeirao Preto
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: