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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00137800

Collaborator

Massachusetts General Hospital (Other), Brigham and Women's Hospital (Other), Genentech, Inc. (Industry)

Enrollment

Locations

Arm

48.9

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma	Drug: OSI-774 (Tarceva)	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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)

Actual Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tarceva Chemotherapy Single Agent Systemic	Drug: OSI-774 (Tarceva) Once daily without interruption as long as there is no disease progression or serious side effects experienced.

Arm

Intervention/Treatment

Experimental: Tarceva

Chemotherapy Single Agent Systemic

Drug: OSI-774 (Tarceva)

Once daily without interruption as long as there is no disease progression or serious side effects experienced.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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