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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Jan P. Van Meerbeeck, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitair Ziekenhuis Gent
Authority:
United States: Federal Government
Study ID:
EORTC-08021
NCT ID:
NCT00091156
Start Date:
May 2004
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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