NCT00137800

Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	OSI-774 (Tarceva)	Once daily without interruption as long as there is no disease progression or serious side effects experienced.

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-05-01
• Completion: 2007-03-01
• First posted: 2005-08-30
• Last updated: 2020-04-03

Locations

2 sites across 1 country: United States