OSI-774 (Erlotinib, Tarceva) in Elderly Patients

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Tarceva

• Registration Number: NCT00200395
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2003-07-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2007-01-12
• Study Completion: 2007-01-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OSI-774 (Tarceva)	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.

Primary Outcome Measures

Name	Time	Method
Rate of Response	1-3 years	The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date the recurrent or progressive disease is documented.

Secondary Outcome Measures

Name	Time	Method
Rate of Progression free survival	1-3 years	Progression free survival is defined as the duration of time from start of treatment to time of progression.
Duration of stable disease	1-3 years	Stable disease is measured from the start of the treatment until the criteris for progression are met., taking as reference the smallest measurements recorded since the treatment started.
Overall Rate of Survival	Up to 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v2.0	1-3 years
Changes in Quality of Life (QOL): questionnaire	through study completion, an average of 3 years	This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire.

Trial Locations

Locations (4)

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

New York University; 🇺🇸 New York, New York, United States

Albert Einstein Cancer Center; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center-; 🇺🇸 Bronx, New York, United States