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

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma, Non-small Cell Lung Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine how well non-small cell lung cancer cells in the body respond to Tarceva

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Pasi A Janne, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

April 2013

Related Keywords:

  • Adenocarcinoma
  • Non-Small Cell Lung Cancer
  • Tarceva
  • Erlotinib
  • OSI-774
  • Adenocarcinoma
  • Advanced Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617