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

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091156

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: gefitinib Procedure: adjuvant therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Toxicity as assessed by CTC [ Designated as safety issue: Yes ]

Estimated Enrollment:	598
Study Start Date:	May 2004
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091156

Locations

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

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:	Jan P. Van Meerbeeck, MD, PhD	Universitair Ziekenhuis Gent
Investigator:	Giorgio Scagliotti, MD, PhD	Azienda Ospedale S. Luigi at University of Torino

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000384069, EORTC-08021, ILCP-01/03, EUDRACT-2004-001331-36
Study First Received:	September 7, 2004
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00091156
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009