This trial is active, not recruiting.

Condition non-small-cell lung carcinoma
Treatment osi-774 (tarceva)
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator Massachusetts General Hospital
Start date February 2003
End date May 2005
Trial size 80 participants
Trial identifier NCT00137800, 02-308


The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To determine how well non-small cell lung cancer cells in the body respond to OSI-774
time frame: 2 years
To determine the survival rate of patients treated with OSI-774
time frame: TBD

Secondary Outcomes

To determine the safety of OSI-774 in people 70 years of age or older
time frame: 2 years
To see how OSI-774 affects overall quality of life
time frame: 2 years

Eligibility Criteria

Male or female participants at least 70 years old.

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, etc. - 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 study

Additional Information

Official title A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Principal investigator Pasi A Janne, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.