MedDataX Logo

OSI-774 (Erlotinib, Tarceva) in Elderly Patients

NCT ID: NCT00200395

Last Updated: 2019-12-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-02

Study Completion Date

2007-01-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OSI-774 (Tarceva)

Oral treatment with OSI-774 (Tarceva) will be given as a 150 mg tablets daily for 14 days. On day 15 and if there are no adverse effects the dose will be increased to 200 mg.

Group Type EXPERIMENTAL

Tarceva

Intervention Type DRUG

OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tarceva

OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OSI-774 Erlotinib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have confirmed non-small cell lung cancer. Age \> 65 years Patients must have adequate organ and marrow function

Exclusion Criteria

* Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lakshmi Rajdev, M.D.

Role: STUDY_CHAIR

Montefiore Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beth Israel Medical Center

New York, New York, United States

Site Status

New York University

New York, New York, United States

Site Status

Albert Einstein Cancer Center

The Bronx, New York, United States

Site Status

Montefiore Medical Center-

The Bronx, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

03-01-019

Identifier Type: -

Identifier Source: org_study_id