Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)|
- To determine how well non-small cell lung cancer cells in the body respond to OSI-774 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine the survival rate of patients treated with OSI-774 [ Time Frame: TBD ] [ Designated as safety issue: No ]
- To determine the safety of OSI-774 in people 70 years of age or older [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To see how OSI-774 affects overall quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
Drug: OSI-774 (Tarceva)
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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Pasi A Janne, MD, PhD||Dana-Farber Cancer Institute|