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

NCT00091156 | Terminated Phase 3

• 3 other identifiers: EORTC-08021ILCP-01/032004-001331-36
• Study Type: interventional
• Target: 598
• Locations: 5 countries
• Sites: 28

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (2)

• Progression-free survival

• Toxicity as assessed by CTC

Interventions

gefitinib DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (28)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, B-2020, Belgium

Location

Ghent University

Ghent, B-9000, Belgium

Location

CHR - Clinique Saint Joseph - Hopital de Warqueguies

Mons, B-7000, Belgium

Location

Clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Bank Of Cyprus Oncology Centre

Nicosia, 2006 Strovolos, Cyprus

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Presidio Ospedaliero di Livorno

Livorno, 57100, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Ospedale Niguarda Ca'Granda

Milan, 20162, Italy

Location

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

Location

Azienda Ospedaliera Maggiore Della Carita

Novara, 28100, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, 10043, Italy

Location

Azienda Ospedaliera Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

Azienda Ospedaliera "Santa Maria Degli Angeli"

Pordenone, 33170, Italy

Location

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, 42100, Italy

Location

Azienda Ospedaliera S. Camillo-Forlanini

Rome, 00152, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Ospedale Civile Maggiore - Borgo Trento

Verona, 37126, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

Kennemer Gasthuis - Locatie EG

Haarlem, 2000, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

St. Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 21802939 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jan P. Van Meerbeeck, MD, PhD

  University Ghent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: May 1, 2004
• Primary Completion: July 1, 2008
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

NL (5); CY (1); BE (4); EG (1); IT (17)