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CompletedPhase 2NCT00137839
Official study title

Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedErlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 17, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Pasi A. Janne, MD, PhD

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Pasi A. Janne, MD, PhD
Interventions being studied
Drug: Erlotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 17, 2019. Always confirm current availability with the study team.

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