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CompletedPhase 2NCT00137800
Official study title

Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

Study summary

The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedOSI-774 (Tarceva)

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 Apr 3, 2020 · 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?2 U.S. locations

Locations may change over time.

Who runs it?Dana-Farber Cancer Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Dana-Farber Cancer Institute
Interventions being studied
Drug: OSI-774 (Tarceva)
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)→
Treatment approach
Chemotherapy→
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
  • Age: 70 years of age or older
  • Stage IV or IIIB non-small cell lung cancer (NSCLC)
  • Measurable tumor(s)
  • Three or more weeks since prior radiation therapy
  • Three or more weeks since prior major surgery
  • Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
  • Must be up and about more than 50% of waking hours.
  • Life expectancy of 8 weeks or more
  • Blood tests that show kidneys, liver and bone marrow to be working adequately
  • Completely healed from previous oncologic or other major surgery
Reasons someone may not be able to joinExclusion criteria
  • Prior chemotherapy regimen for non-small cell lung cancer
  • Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225, etc.
  • Uncontrolled central nervous system metastases
  • Concurrent active cancer
  • Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  • Prior chemotherapy for any malignant disease
  • Difficulty swallowing
  • A disease or disorder that interferes with ability to digest and absorb food
  • 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
  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 3, 2020. Always confirm current availability with the study team.

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