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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00091156
• Other study ID #: EORTC-08021
• Secondary ID: EORTC-08021ILCP-
• Status: Terminated
• Phase: Phase 3
• First received: September 7, 2004
• Last updated: July 13, 2012
• Start date: May 2004

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 598
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gefitinib

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Belgium	Ziekenhuis Netwerk Antwerpen Middelheim	Antwerpen
Belgium	Ghent University	Ghent
Belgium	CHR - Clinique Saint Joseph - Hopital de Warqueguies	Mons
Belgium	Clinique Sainte Elisabeth	Namur
Cyprus	Bank Of Cyprus Oncology Centre	Nicosia
Egypt	National Cancer Institute of Egypt	Cairo
Italy	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
Netherlands	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

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Cyprus,  Egypt,  Italy,  Netherlands, 

References & 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 g — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Progression-free survival			No
Secondary	Toxicity as assessed by CTC			Yes