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Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Primary Purpose

Adenocarcinoma, Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Pasi A. Janne, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring Tarceva, Erlotinib, OSI-774, Adenocarcinoma, Advanced Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib

Arm 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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
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

Overall Response Rate (ORR) by EGFR Mutation Status
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.
Overall Survival (OS)
OS is defined as the time from study entry to death or date last known alive.
Overall Survival by EGFR Mutation Status
OS is defined as the time from study entry to death or date last known alive.

Full Information

First Posted
August 29, 2005
Last Updated
December 7, 2019
Sponsor
Pasi A. Janne, MD, PhD
Collaborators
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00137839
Brief Title
Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
Official Title
A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pasi A. Janne, MD, PhD
Collaborators
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Non-small Cell Lung Cancer
Keywords
Tarceva, Erlotinib, OSI-774, Adenocarcinoma, Advanced Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva, OSI-774
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) by EGFR Mutation Status
Description
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.
Time Frame
In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Title
Overall Survival (OS)
Description
OS is defined as the time from study entry to death or date last known alive.
Time Frame
In this study cohort, participants were followed for survival up to 155 months.
Title
Overall Survival by EGFR Mutation Status
Description
OS is defined as the time from study entry to death or date last known alive.
Time Frame
In this study cohort, participants were followed for survival up to 155 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasi A Janne, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16014882
Citation
Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
Results Reference
background
PubMed Identifier
15310767
Citation
Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47. doi: 10.1200/JCO.2004.11.057.
Results Reference
background
PubMed Identifier
15886310
Citation
Janne PA, Engelman JA, Johnson BE. Epidermal growth factor receptor mutations in non-small-cell lung cancer: implications for treatment and tumor biology. J Clin Oncol. 2005 May 10;23(14):3227-34. doi: 10.1200/JCO.2005.09.985.
Results Reference
background
PubMed Identifier
15118125
Citation
Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004 Jun 4;304(5676):1497-500. doi: 10.1126/science.1099314. Epub 2004 Apr 29.
Results Reference
background
Links:
URL
https://www.dana-farber.org/thoracic-lung-cancer-treatment-center/
Description
Dana-Farber Cancer Institute Lowe Thoracic Oncology Program

Learn more about this trial

Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

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