Phase II Iressa & Carbo/Gem in NSCLC

June 11, 2009 updated by: AstraZeneca

A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2

The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site

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:

  • Advanced Non Small cell Lung Cell Lung cancer
  • Never received chemotherapy
  • Up and about 50% of waking hours

Exclusion Criteria:

  • Spread of lung cancer to the brain
  • Low level of white blood cells
  • Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.

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: 2
Gefitinib
Drug: Gefitinib
oral tablet
Other Names:
  • ZD1839
  • IRESSA
Active Comparator: 1
Gemcitabine + Carboplatin
Drug: Carboplatin
intravenous injection
Other Names:
  • CBDCA
Drug: Gemcitabine
intravenous injection
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Date of randomization to earliest date of objective disease progression
Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression
Date of randomization to earliest date of objective disease progression

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Canada Oncology Medical Director, MD, AstraZeneca

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

October 1, 2004

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Estimate)

August 3, 2009

Last Update Submitted That Met QC Criteria

June 11, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0551

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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