Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

August 6, 2012 updated by: OSI Pharmaceuticals

A Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers

This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

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 Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge, United Kingdom, CB2 2RE
        • CR UK
      • Cambridge, United Kingdom, PE3 6DA
        • Peterborough District Hospital
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncology Centre
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
  • United States
    • California
      • Alhambra, California, United States, 91801
        • Central Hematology Oncology Medical Group Inc.
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center(Part of TORI network)
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • Fullerton, California, United States, 92835
        • Virginia K. Crosson Cancer Center
      • Long Beach, California, United States, 90813-3244
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095-7077
        • UCLA Medical Center
      • Northridge, California, United States, 91325
        • North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group, Inc.
      • Santa Barbara, California, United States, 93105
        • Sansum Santa Barbara Medical Foundation Clinic
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hematology Oncology Medical Group, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer CenterResearch Department
    • Connecticut
      • Norwich, Connecticut, United States, 06360-2910
        • Eastern Connecticut Hematology and Oncology Associates
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Ctr - Orlando
      • Tampa, Florida, United States, 33614
        • Gulfcoast Oncology Associates
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
        • Suburban Hematology-Oncology Associates
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St.Luke's Med Ctr
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ. of Minnesota Cancer Center
    • Montana
      • Billings, Montana, United States, 59101
        • Hematology Oncology Centers of Northern Rockies Research
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Alegent Healthcare
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Mount Holly, New Jersey, United States, 08060
        • Hematology-Oncology Associates, SJ, PA - Virtua Health
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pottsville, Pennsylvania, United States, 17901
        • Pottsville Cancer Clinic
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Cancer Clinic
      • Memphis, Tennessee, United States, 38104
        • Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.
      • Memphis, Tennessee, United States, 38138
        • ACORN
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Cancer Specialists of Tidewater, Ltd.
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research 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:

  • Age >= 18
  • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
  • Radiologically measurable or evaluable disease No prior chemotherapy
  • 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
  • Tumor tissue block or fine needle aspirate

Exclusion Criteria:

  • Any concurrent anticancer therapy or radiation
  • Other active malignancy
  • Uncontrolled brain metastases
  • GI abnormalities
  • Severe abnormalities of the cornea
  • Significant cardiac disease
  • Active infection

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
150 mg erlotinib daily
Drug: Tarceva
oral tablet
Other Names:
  • OSI-774
  • erlotinib
Experimental: Erlotinib + chemotherapy (intercalated)
carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
Drug: carboplatin
IV
Drug: paclitaxel
IV
Drug: Tarceva
oral tablet
Other Names:
  • OSI-774
  • erlotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month Progression-free Survival
Time Frame: 6 months after first dose
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
6 months after first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 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, as assessed every 21 days (maximum 28.8 months)
Overall Survival at 12 Months
Time Frame: 12 months from 1st dose
Percentage of patients alive after 12 months of study treatment
12 months from 1st dose
Overall Survival
Time Frame: From first study treatment until time of death (maximum 29.0 months)
Median number of months from first study treatment until time of death
From first study treatment until time of death (maximum 29.0 months)
Best Tumor Response
Time Frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
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 larger than at baseline
While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
Duration of Tumor Response
Time Frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
Median length of time that tumor showed any type of response, ie, CR, PR, or SD
While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).

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.

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

January 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 22, 2006

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-774-203

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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