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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00585533
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : November 21, 2012
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Drug: Erlotinib (Tarceva) Phase 2

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : June 2004
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
A Drug: Erlotinib (Tarceva)
Erlotinib
Other Name: Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Survival Rate at 6-months Chemotherapy-progression-free (CP-free) [ Time Frame: 6 months ]
    Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 24 months ]
    Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585533


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Wallace Akerley, MD University of Utah
More Information
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585533    
Obsolete Identifiers: NCT00204724
Other Study ID Numbers: HCI12555
IRB# 00012555
First Posted: January 3, 2008    Key Record Dates
Results First Posted: November 21, 2012
Last Update Posted: July 30, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action