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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00585533
First received: December 26, 2007
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Survival Rate at 6-months Chemotherapy-progression-free (CP-free) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.


Enrollment: 40
Study Start Date: June 2004
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A Drug: Erlotinib (Tarceva)
Erlotinib
Other Name: Tarceva

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

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585533     History of Changes
Obsolete Identifiers: NCT00204724
Other Study ID Numbers: HCI12555, IRB# 00012555
Study First Received: December 26, 2007
Results First Received: June 4, 2012
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013