Skip to main content
OpenTrials
Completed

NCT Number: NCT00137839

Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib

Drug

Other names: Tarceva, OSI-774

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

    ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.

Secondary outcomes

  1. Overall Response Rate (ORR) by EGFR Mutation Status

    Time frame: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

    ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.

  2. Overall Survival (OS)

    Time frame: In this study cohort, participants were followed for survival up to 155 months.

    OS is defined as the time from study entry to death or date last known alive.

  3. Overall Survival by EGFR Mutation Status

    Time frame: In this study cohort, participants were followed for survival up to 155 months.

    OS is defined as the time from study entry to death or date last known alive.

Sponsors and collaborators

Lead sponsor

Pasi A. Janne, MD, PhD

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Massachusetts General Hospital

Registry information

Official study title

A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung

Important dates

Study start
2004
Primary completion
2008
Study completion
2019
First posted
Aug 30, 2005
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.