Lung CancerPhase 3NCT00091156
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 3 study testing gefitinib and adjuvant therapy in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- gefitinib and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 598 participants
- Where
- 28 sitesin 5 countries
- Study dates
- May 2004to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
Italy17 sites
Ospedali Riuniti di Bergamo
Bergamo, 24100
Ospedale Santa Croce
Cuneo, 12100
Universita di Ferrara
Ferrara, 44100
Presidio Ospedaliero di Livorno
Livorno, 57100
Ospedale Luigi Sacco
Milan, 20157
Ospedale Niguarda Ca'Granda
Milan, 20162
Azienda Ospedaliera - Universitaria di Modena
Modena, 41100
Azienda Ospedaliera Maggiore Della Carita
Novara, 28100
Azienda Ospedale S. Luigi at University of Torino
Orbassano, 10043
Azienda Ospedaliera Policlinico Paolo Giaccone
Palermo, 90127
Azienda Ospedaliera Di Parma
Parma, 43100
Azienda Ospedaliera "Santa Maria Degli Angeli"
Pordenone, 33170
Ospedale Sta. Maria Delle Croci
Ravenna, 48100
Arcispedale S. Maria Nuova
Reggio Emilia, 42100
Azienda Ospedaliera S. Camillo-Forlanini
Rome, 00152
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Ospedale Civile Maggiore - Borgo Trento
Verona, 37126
Netherlands5 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5211 NL
Rijnstate Hospital
Arnhem, 6800 TA
Kennemer Gasthuis - Locatie EG
Haarlem, 2000
Leiden University Medical Center
Leiden, 2300 RC
St. Franciscus Gasthuis
Rotterdam, 3045 PM
Belgium4 sites
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, B-2020
Ghent University
Ghent, B-9000
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, B-7000
Clinique Sainte Elisabeth
Namur, 5000
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- gefitinib, adjuvant therapy
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (2)
Progression-free survival
Toxicity as assessed by CTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2004 (estimated)
- Study startMay 2004
- Primary completionJul 2008
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 598 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jan P. Van Meerbeeck, MD, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091156
- Sponsor's protocol ID
- EORTC-08021
- Other IDs
- EORTC-08021, ILCP-01/03, 2004-001331-36, 2004
- Status last verified
- Jul 2012
- First submitted
- 7 Sep 2004
- Last updated
- 16 Jul 2012
- Results posted
- No
Publications
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.
PubMed 21802939
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00091156
- Acronym / sponsor ID
- EORTC-08021
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 598 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2004
- Primary completion
- Jul 2008 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gefitinib | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Overall survival
2 secondary outcomes
Progression-free survival
Toxicity as assessed by CTC
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Results publication: PubMed 21802939Gaafar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan P. Van Meerbeeck, MD, PhD study chair
University Ghent
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gefitinib and adjuvant therapy in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, Netherlands, Belgium, Cyprus, Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.