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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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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

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Non-Small-Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tarceva

Chemotherapy Single Agent Systemic

Group Type EXPERIMENTAL

OSI-774 (Tarceva)

Intervention Type DRUG

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

Interventions

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OSI-774 (Tarceva)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes