Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

OSI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Failed Prior Chemotherapy; Advanced Non Small Cell Lung Cancer

Treatments: Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00072631

OSI-774-202

Dose to Rash

Details and patient eligibility

About

The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Full description

Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
• Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
• Measurable disease per RECIST criteria.
• Adequate bone marrow, hepatic and renal function.

Exclusion criteria

• Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
• Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
• Known hypersensitivity to minocycline.
• History of serious cardiac disease that is not controlled.
• Serious eye conditions.
• Prior treatment with inhibitors of EGFR of any kind.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

1 erlotinib

Experimental group

Treatment:

Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)