OSI-774 (Erlotinib, Tarceva) in Elderly Patients

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200395
• Other study ID #: 03-01-019
• Status: Completed
• Phase: Phase 2
• Start date: July 2, 2003
• Est. completion date: January 12, 2007

Study information

• Verified date: December 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 12, 2007
• Est. primary completion date: January 12, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Albert Einstein Cancer Center	Bronx	New York
United States	Montefiore Medical Center-	Bronx	New York
United States	Beth Israel Medical Center	New York	New York
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Response	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.	1-3 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v2.0		1-3 years
Secondary	Changes in Quality of Life (QOL): questionnaire	This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire.	through study completion, an average of 3 years
Secondary	Rate of Progression free survival	Progression free survival is defined as the duration of time from start of treatment to time of progression.	1-3 years
Secondary	Duration of stable disease	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.	1-3 years
Secondary	Overall Rate of Survival		Up to 5 years