Status:
TERMINATED
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 dela...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT00091156
Start Date
May 1 2004
Last Update
July 16 2012
Active Locations (28)
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1
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Belgium, B-2020
2
Ghent University
Ghent, Belgium, B-9000
3
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, Belgium, B-7000
4
Clinique Sainte Elisabeth
Namur, Belgium, 5000