Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00091156
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 598
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival Toxicity as assessed by CTC
Trial Locations
- Locations (28)
Clinique Sainte Elisabeth
🇧🇪Namur, Belgium
Bank Of Cyprus Oncology Centre
🇨🇾Nicosia, Cyprus
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Ospedale Santa Croce
🇮🇹Cuneo, Italy
Azienda Ospedale S. Luigi at University of Torino
🇮🇹Orbassano, Italy
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerpen, Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
🇧🇪Mons, Belgium
Azienda Ospedaliera Maggiore Della Carita
🇮🇹Novara, Italy
Azienda Ospedaliera Di Parma
🇮🇹Parma, Italy
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Ospedale Luigi Sacco
🇮🇹Milan, Italy
Azienda Ospedaliera - Universitaria di Modena
🇮🇹Modena, Italy
Azienda Ospedaliera Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Ghent University
🇧🇪Ghent, Belgium
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Universita di Ferrara
🇮🇹Ferrara, Italy
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Ospedale Niguarda Ca'Granda
🇮🇹Milan, Italy
Ospedale Sta. Maria Delle Croci
🇮🇹Ravenna, Italy
Kennemer Gasthuis - Locatie EG
🇳🇱Haarlem, Netherlands
St. Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
Azienda Ospedaliera "Santa Maria Degli Angeli"
🇮🇹Pordenone, Italy
Presidio Ospedaliero di Livorno
🇮🇹Livorno, Italy
Azienda Ospedaliera S. Camillo-Forlanini
🇮🇹Rome, Italy
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Ospedale Civile Maggiore - Borgo Trento
🇮🇹Verona, Italy