Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT00091156
Last Updated: 2012-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
598 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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gefitinib
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Jan P. Van Meerbeeck, MD, PhD
Role: STUDY_CHAIR
University Ghent
Locations
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Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, , Belgium
Ghent University
Ghent, , Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, , Belgium
Clinique Sainte Elisabeth
Namur, , Belgium
Bank Of Cyprus Oncology Centre
Nicosia, , Cyprus
National Cancer Institute of Egypt
Cairo, , Egypt
Ospedali Riuniti di Bergamo
Bergamo, , Italy
Ospedale Santa Croce
Cuneo, , Italy
Universita di Ferrara
Ferrara, , Italy
Presidio Ospedaliero di Livorno
Livorno, , Italy
Ospedale Luigi Sacco
Milan, , Italy
Ospedale Niguarda Ca'Granda
Milan, , Italy
Azienda Ospedaliera - Universitaria di Modena
Modena, , Italy
Azienda Ospedaliera Maggiore Della Carita
Novara, , Italy
Azienda Ospedale S. Luigi at University of Torino
Orbassano, , Italy
Azienda Ospedaliera Policlinico Paolo Giaccone
Palermo, , Italy
Azienda Ospedaliera Di Parma
Parma, , Italy
Azienda Ospedaliera "Santa Maria Degli Angeli"
Pordenone, , Italy
Ospedale Sta. Maria Delle Croci
Ravenna, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Azienda Ospedaliera S. Camillo-Forlanini
Rome, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale Civile Maggiore - Borgo Trento
Verona, , Italy
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Kennemer Gasthuis - Locatie EG
Haarlem, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
St. Franciscus Gasthuis
Rotterdam, , Netherlands
Countries
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References
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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.
Other Identifiers
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EORTC-08021
Identifier Type: -
Identifier Source: secondary_id
ILCP-01/03
Identifier Type: -
Identifier Source: secondary_id
2004-001331-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EORTC-08021
Identifier Type: -
Identifier Source: org_study_id