NCT00091156TerminatedPhase 3
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
European Organisation for Research and Treatment of Cancer - EORTC55 sites in 5 countries598 target enrollmentStarted: May 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 598
- Locations
- 55
- Primary Endpoint
- Overall survival
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •No history, signs, or symptoms of clinically active interstitial lung disease
- •Patients with chronic, stable, asymptomatic radiographic changes are eligible
- •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
- •Not specified
- •No prior epidermal growth factor receptor inhibitors
- •No concurrent administration of any of the following drugs:
- •Phenytoin
- •Carbamazepine
- •Phenobarbital
- •Hypericum perforatum (St. John's wort)
- •No other concurrent anticancer therapy
- •No other concurrent experimental drugs
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall survival
Secondary Outcomes
- Progression-free survival
- Toxicity as assessed by CTC
Investigators
Study Sites (55)
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