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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
gefitinib
adjuvant therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Ghent University
  • CHR - Clinique Saint Joseph - Hopital de Warqueguies
  • Clinique Sainte Elisabeth
  • Bank Of Cyprus Oncology Centre
  • National Cancer Institute of Egypt
  • Ospedali Riuniti di Bergamo
  • Ospedale Santa Croce
  • Universita di Ferrara
  • Presidio Ospedaliero di Livorno
  • Ospedale Luigi Sacco
  • Ospedale Niguarda Ca'Granda
  • Azienda Ospedaliera - Universitaria di Modena
  • Azienda Ospedaliera Maggiore Della Carita
  • Azienda Ospedale S. Luigi at University of Torino
  • Azienda Ospedaliera Policlinico Paolo Giaccone
  • Azienda Ospedaliera Di Parma
  • Azienda Ospedaliera "Santa Maria Degli Angeli"
  • Ospedale Sta. Maria Delle Croci
  • Arcispedale S. Maria Nuova
  • Azienda Ospedaliera S. Camillo-Forlanini
  • Ospedale di Circolo e Fondazione Macchi
  • Ospedale Civile Maggiore - Borgo Trento
  • Jeroen Bosch Ziekenhuis
  • Rijnstate Hospital
  • Kennemer Gasthuis - Locatie EG
  • Leiden University Medical Center
  • St. Franciscus Gasthuis

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival
Toxicity as assessed by CTC

Full Information

First Posted
September 7, 2004
Last Updated
July 13, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00091156
Brief Title
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
May 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
598 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Toxicity as assessed by CTC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan P. Van Meerbeeck, MD, PhD
Organizational Affiliation
Universitair Ziekenhuis Gent
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerpen
ZIP/Postal Code
B-2020
Country
Belgium
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
CHR - Clinique Saint Joseph - Hopital de Warqueguies
City
Mons
ZIP/Postal Code
B-7000
Country
Belgium
Facility Name
Clinique Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Bank Of Cyprus Oncology Centre
City
Nicosia
ZIP/Postal Code
2006 Strovolos
Country
Cyprus
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Ospedale Santa Croce
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Universita di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Presidio Ospedaliero di Livorno
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale Niguarda Ca'Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera Maggiore Della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedale S. Luigi at University of Torino
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Azienda Ospedaliera "Santa Maria Degli Angeli"
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale Sta. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Azienda Ospedaliera S. Camillo-Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Ospedale Civile Maggiore - Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6800 TA
Country
Netherlands
Facility Name
Kennemer Gasthuis - Locatie EG
City
Haarlem
ZIP/Postal Code
2000
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
St. Franciscus Gasthuis
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21802939
Citation
Gaafar RM, Surmont VF, Scagliotti GV, Van Klaveren RJ, Papamichael D, Welch JJ, Hasan B, Torri V, van Meerbeeck JP; EORTC Lung Cancer Group and the Italian Lung Cancer Project. A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03). Eur J Cancer. 2011 Oct;47(15):2331-40. doi: 10.1016/j.ejca.2011.06.045. Epub 2011 Jul 28.
Results Reference
result

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

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