Clinical trial NCT00091156: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2004-09-08
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Progression-free survival
measure: Toxicity as assessed by CTC
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Middelheim
city: Ghent
country: Belgium
facility: Ghent University
city: Mons
country: Belgium
facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies
city: Namur
country: Belgium
facility: Clinique Sainte Elisabeth
city: Nicosia
country: Cyprus
facility: Bank Of Cyprus Oncology Centre
city: Cairo
country: Egypt
facility: National Cancer Institute of Egypt
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Cuneo
country: Italy
facility: Ospedale Santa Croce
city: Ferrara
country: Italy
facility: Universita di Ferrara
city: Livorno
country: Italy
facility: Presidio Ospedaliero di Livorno
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Milan
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Modena
country: Italy
facility: Azienda Ospedaliera - Universitaria di Modena
city: Novara
country: Italy
facility: Azienda Ospedaliera Maggiore Della Carita
city: Orbassano
country: Italy
facility: Azienda Ospedale S. Luigi at University of Torino
city: Palermo
country: Italy
facility: Azienda Ospedaliera Policlinico Paolo Giaccone
city: Parma
country: Italy
facility: Azienda Ospedaliera Di Parma
city: Pordenone
country: Italy
facility: Azienda Ospedaliera "Santa Maria Degli Angeli"
city: Ravenna
country: Italy
facility: Ospedale Sta. Maria Delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Rome
country: Italy
facility: Azienda Ospedaliera S. Camillo-Forlanini
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Verona
country: Italy
facility: Ospedale Civile Maggiore - Borgo Trento
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis - Locatie EG
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: St. Franciscus Gasthuis
Study officials:
affiliation: Universitair Ziekenhuis Gent
name: Jan P. Van Meerbeeck, MD, PhD
role: STUDY_CHAIR
References:
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.