Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

August 6, 2012 updated by: OSI Pharmaceuticals

A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Greenbrae, California, United States, 94904
        • California Cancer Care, Inc.
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Cancer Center
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
      • Peoria, Illinois, United States, 61615
        • Oncology/Hematology Associates of Central Illinois
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare, Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Maryland Hematology/Oncology Associates
    • Nevada
      • Reno, Nevada, United States, 89502
        • VA Sierra Nevada Health Care System
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • North Dakota
      • Bismarck, North Dakota, United States, 58503
        • FEK Addo, PC
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, United States, 43210-1240
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • East Tennessee Oncology/Hematology, PC
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
  • No prior chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 2
  • Clinically or radiologically measurable disease per RECIST criteria

Exclusion Criteria:

  • Gastro-intestinal abnormalities
  • Any concurrent anticancer therapy
  • Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
  • Other active malignancies
  • Uncontrolled brain metastases
  • Severe abnormalities of the cornea
  • Significant cardiac disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Active Comparator: Standard Chemotherapy
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
Drug: Combination carboplatin and paclitaxel
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Until time of disease progression (maximum 5 months)
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Until time of disease progression (maximum 5 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From first study treatment until time of death (maximum 26.8 months)
Median number of months from first study treatment until time of death
From first study treatment until time of death (maximum 26.8 months)
Best Tumor Response
Time Frame: While receiving study treatment (maximum 60 weeks)
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.
While receiving study treatment (maximum 60 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

June 15, 2004

First Submitted That Met QC Criteria

June 16, 2004

First Posted (Estimate)

June 17, 2004

Study Record Updates

Last Update Posted (Estimate)

August 9, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-774-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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