Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Pasi A. Janne, MD, PhD

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer; Adenocarcinoma

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00137839

04-253

Details and patient eligibility

About

The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

Full description

Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Diagnosis of adenocarcinoma of the lung
• Patient has had at least one core biopsy of her tumor
• Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
• Stage four (IV) or three (III) B non-small cell lung cancer
• Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
• Three or more weeks since last radiation therapy
• Three or more weeks since last major surgery
• Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
• Life expectancy of 8 weeks or more
• Blood tests that show kidneys, liver and bone marrow to be working adequately
• Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study

Exclusion criteria

• Prior exposure to Tarceva (OSI-774, erlotinib)
• Uncontrolled central nervous system problems
• Prior chemotherapy regimen
• Difficulty swallowing
• A disease or disorder that interferes with ability to digest and absorb food
• Incomplete healing of previous oncologic or other major surgery
• Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
• Pregnant or breast feeding
• A medical condition that could make it unsafe for patient to participate in this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Erlotinib

Experimental group

Description:

Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.

Treatment:

Drug: Erlotinib