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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137800

Enrollment

Registered

2005-08-30

Start date

2003-02-28

Completion date

2007-03-31

Last updated

2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

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

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.

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.

Interventions

DRUGOSI-774 (Tarceva)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026