Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung
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ClinicalTrials.gov Identifier: NCT00137839 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 30, 2005
Last Update Posted
: August 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma Non-small Cell Lung Cancer | Drug: Erlotinib | Phase 2 |
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.
Every 28 days (one cycle) while the patient is taking Tarceva, they will be examined in the outpatient clinic (blood test and physical examination) and the doctor will determine if they should continue taking Tarceva.
After every two cycles of treatment (every 8 weeks) standard radiological testing (CT scans, MRIs, and/or x-rays) of the cancer site(s) will be done to assess the response to the Tarceva treatment.
While the patient is on this study and at the end of the study, the patient will undergo blood and urine tests, medical history evaluation, physical exams including measures of vital signs (blood pressure, heart rate, temperature, and respiration), bone scans, tumor biopsy sample, and various radiological tests to monitor the cancer and the patients health.
The length of time on the study depends upon how the cancer responds to Tarceva and whether or not the patient experiences unacceptable side effects.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
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 |
Study Start Date : | October 2004 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2016 |

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Drug: Erlotinib
- Tarceva
- OSI-774
- To determine how well non-small cell lung cancer cells in the body respond to Tarceva [ Time Frame: 4 years ]
- To determine the safety of Tarceva and what effects it has on women with adenocarcinoma of the lung [ Time Frame: 4 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 IV or IIIB 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

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
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 |
Principal Investigator: | Pasi A Janne, MD, PhD | Dana-Farber Cancer Institute |
Publications:
Responsible Party: | Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00137839 History of Changes |
Other Study ID Numbers: |
04-253 |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | August 3, 2016 |
Last Verified: | July 2016 |
Keywords provided by Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute:
Tarceva Erlotinib OSI-774 Adenocarcinoma Advanced Lung Cancer |
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung Adenocarcinoma Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |