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A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
70 Years
Open (Enrolling)
Non-Small-Cell Lung Carcinoma

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Trial Information

A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Patients will receive OSI-774 once daily without interruption. There are no pre-determined
number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity
and efficacy, a four week (28 day period) will be considered 1 cycle.

Patients will continue to receive OSI-774 until they develop progressive disease,
unacceptable side-effects or wish to withdraw from the study.

Patients will have radiographic evaluations after every two cycles of therapy. After cycle
2, patients will also be evaluated by FDG-PET scanning.

Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day
of each cycle.

Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.

Inclusion Criteria:

- Age: 70 years of age or older

- Stage IV or IIIB non-small cell lung cancer (NSCLC)

- Measurable tumor(s)

- Three or more weeks since prior radiation therapy

- Three or more weeks since prior major surgery

- Must at least be able to walk and capable of taking care of oneself although unable
to carry out work activities.

- Must be up and about more than 50% of waking hours.

- Life expectancy of 8 weeks or more

- Blood tests that show kidneys, liver and bone marrow to be working adequately

- Completely healed from previous oncologic or other major surgery

Exclusion Criteria:

- Prior chemotherapy regimen for non-small cell lung cancer

- Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225,

- Uncontrolled central nervous system metastases

- Concurrent active cancer

- Malignancies within the past 5 years except for adequately treated carcinoma of the
cervix or basal or squamous cell carcinomas of the skin

- Prior chemotherapy for any malignant disease

- Difficulty swallowing

- A disease or disorder that interferes with ability to digest and absorb food

- A medical condition that could make it unsafe for patient to participate in this

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: 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 OSI-774

Outcome Time Frame:

2 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:

February 2003

Completion Date:

December 2013

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Non-Small Cell Lung Cancer
  • Elderly Cancer Patients
  • Tarceva
  • Erlotinib
  • OSI-774
  • Stage IIIB or IV Non-Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617