OSI-774 (Erlotinib, Tarceva) in Elderly Patients

NCT00200395 | Completed Phase 2 FDA Drug

• 1 other identifier: 03-01-019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Rate of Progression free survival

  1-3 years

• Duration of stable disease

  1-3 years

• Overall Rate of Survival

  Up to 5 years

Study Arms (1)

OSI-774 (Tarceva)

EXPERIMENTAL

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.

Drug: Tarceva

Interventions

Tarceva 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.

Also known as: OSI-774, Erlotinib

OSI-774 (Tarceva)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (4)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

New York University

New York, New York, 10016, United States

Location

Albert Einstein Cancer Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center-

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lakshmi Rajdev, M.D.

  Montefiore Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 2, 2003
• Primary Completion: January 12, 2007
• Study Completion: January 12, 2007
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

US (4)