First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven or radiologically and clinically suspected stage IIIB (with malignant pleural effusion) or IV non-small cell lung cancer
- Unresectable disease
- At least 1 measurable lesion (> 10 mm with spiral CT scan or > 20 mm with conventional CT scan)
- No symptomatic or untreated brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin > 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- AST and ALT < 2 times upper limit of normal (ULN)
- Bilirubin < 1.5 mg/dL
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
No serious uncontrolled systemic intercurrent illness, including any of the following:
- Acute myocardial infarction
- Uncontrolled arrhythmia
- Uncontrolled heart failure
- Sepsis
- Poorly controlled diabetes
- No other malignancy within the last 5 years, except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy, including cranial irradiation
- At least 3 weeks since prior major surgery
- No prior systemic chemotherapy except adjuvant chemotherapy provided it was completed more than 12 months ago
Sites / Locations
- Yonsei Cancer Center at Yonsei University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm I
Arm II, Genotype A1
Arm II, Genotype A2
Arm II, Genotype B1
Arm II, Genotype B2
Patients receive standard chemotherapy of docetaxel and carboplatin.
Patients receive docetaxel and vinorelbine ditartrate.
Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
Patients receive docetaxel and carboplatin.
Patients receive gemcitabine hydrochloride and carboplatin.