A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Doxycline; Drug: erlotinib [Tarceva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531934

ML20829

Details and patient eligibility

About

This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• confirmed non-small cell lung cancer;
• failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva.

Exclusion criteria

• rash of any etiology at study entry;
• history of significant heart disease;
• any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix);
• history of allergic reactions to tetracyclines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Doxycline

Drug: erlotinib [Tarceva]

2

Active Comparator group

Treatment:

Drug: erlotinib [Tarceva]