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

Roche

Status and phase

Completed

Phase 3

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: erlotinib [Tarceva]

Drug: erythromycin [Eritex]

Drug: Fisiogel

Drug: fusidic acid [Verutex]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00718315

ML21450

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.