Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

July 13, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo.

Secondary

  • Compare progression-free survival of patients treated with these regimens.
  • Determine the safety and toxicity of gefitinib in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral gefitinib once daily.
  • Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.

Study Type

Interventional

Enrollment (Anticipated)

598

Phase

  • Phase 3

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

  • Belgium
      • Antwerpen, Belgium, B-2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Ghent, Belgium, B-9000
        • Ghent University
      • Mons, Belgium, B-7000
        • CHR - Clinique Saint Joseph - Hopital de Warqueguies
      • Namur, Belgium, 5000
        • Clinique Sainte Elisabeth
  • Cyprus
      • Nicosia, Cyprus, 2006 Strovolos
        • Bank Of Cyprus Oncology Centre
  • Egypt
      • Cairo, Egypt
        • National Cancer Institute of Egypt
  • Italy
      • Bergamo, Italy, 24100
        • Ospedali Riuniti di Bergamo
      • Cuneo, Italy, 12100
        • Ospedale Santa Croce
      • Ferrara, Italy, 44100
        • Università di Ferrara
      • Livorno, Italy, 57100
        • Presidio Ospedaliero di Livorno
      • Milan, Italy, 20157
        • Ospedale Luigi Sacco
      • Milan, Italy, 20162
        • Ospedale Niguarda Ca'Granda
      • Modena, Italy, 41100
        • Azienda Ospedaliera - Universitaria di Modena
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Orbassano, Italy, 10043
        • Azienda Ospedale S. Luigi at University of Torino
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Policlinico Paolo Giaccone
      • Parma, Italy, 43100
        • Azienda Ospedaliera Di Parma
      • Pordenone, Italy, 33170
        • Azienda Ospedaliera "Santa Maria Degli Angeli"
      • Ravenna, Italy, 48100
        • Ospedale Sta. Maria Delle Croci
      • Reggio Emilia, Italy, 42100
        • Arcispedale S. Maria Nuova
      • Rome, Italy, 00152
        • Azienda Ospedaliera S. Camillo-Forlanini
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
      • Verona, Italy, 37126
        • Ospedale Civile Maggiore - Borgo Trento
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Jeroen Bosch ziekenhuis
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Haarlem, Netherlands, 2000
        • Kennemer Gasthuis - Locatie EG
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center
      • Rotterdam, Netherlands, 3045 PM
        • St. Franciscus Gasthuis

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:

    • Stage IIIB

      • Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy
    • Stage IV disease
  • No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy
  • Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Pulmonary

  • No history, signs, or symptoms of clinically active interstitial lung disease

    • Patients with chronic, stable, asymptomatic radiographic changes are eligible

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
  • No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy (alopecia allowed)
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • No prior epidermal growth factor receptor inhibitors

  • No concurrent administration of any of the following drugs:

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Phenobarbital
    • Hypericum perforatum (St. John's wort)
  • No other concurrent anticancer therapy
  • No other concurrent experimental drugs

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
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Toxicity as assessed by CTC

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Jan P. Van Meerbeeck, MD, PhD, Universitair Ziekenhuis Gent

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

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

May 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 7, 2004

First Submitted That Met QC Criteria

September 7, 2004

First Posted (Estimate)

September 8, 2004

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-08021
  • ILCP-01/03
  • 2004-001331-36 (EudraCT Number)

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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