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Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137839
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : November 22, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
Information provided by (Responsible Party):
Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Non-small Cell Lung Cancer Drug: Erlotinib Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
Actual Study Start Date : November 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib
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.
Drug: Erlotinib
Other Names:
  • Tarceva
  • OSI-774




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137839


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Pasi A. Janne, MD, PhD
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
Investigators
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Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute
Additional Information:
Publications:
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Responsible Party: Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137839    
Other Study ID Numbers: 04-253
First Posted: August 30, 2005    Key Record Dates
Results First Posted: November 22, 2019
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute:
Tarceva
Erlotinib
OSI-774
Adenocarcinoma
Advanced Lung Cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action