A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00585533

Purpose

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Condition	Intervention	Phase
Lung Cancer	Drug: Erlotinib (Tarceva)	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by University of Utah:

Primary Outcome Measures:

The study will be considered successful, if the 6-month chemotherapy-progression-free (CP-free) survival rate is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance will be used. [ Time Frame: June 2004-end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, (first) progression-free survival and CP-free survival will be estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva. [ Time Frame: June 2004-end ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A	Drug: Erlotinib (Tarceva) Erlotinib

Detailed Description:

Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Performance status 0-1.
Weight Loss < 10% in preceding 3 months
Age 18 years and older.
Adjuvant chemotherapy allowed if > 6 months from protocol entry
Adequate Organ Function
Liver enzymes < 2X normal, bilirubin = normal
Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
Creatinine <2.0 mg

Exclusion Criteria:

Not pregnant or lactating.
No Clinical Brain Metastases
No prior chemotherapy for systemic disease
Imminent need for chemotherapy for impending organ dysfunction is not allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585533

Locations

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Wallace Akerley, MD

University of Utah

More Information

Responsible Party:	Univerisity of Utah ( University of Utah )
Study ID Numbers:	HCI 12555, IRB# 00012555
Study First Received:	December 26, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00585533
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009