Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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 or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: Stage IIIB disease* that is not suitable for radical radiotherapy Stage IV disease* NOTE: *Radiographically verified At least 1 measurable lesion by clinical examination or radiography No mixed histologies of small cell lung cancer and NSCLC No clinically apparent brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy At least 12 weeks Hematopoietic WBC ≥ 3,000/mm³ Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL Hepatic AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Alkaline phosphatase < 3 times ULN Bilirubin < 1.5 times ULN Renal Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by ^51Cr-EDTA clearance) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able and willing to participate in the quality of life assessment No pre-existing neuropathy > grade 2 No other malignancy that would preclude study treatment or study comparisons No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation No psychiatric disorder that would preclude study participation No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy No concurrent hormonal therapy except contraceptives or replacement steroids Radiotherapy No prior radiotherapy Surgery Recovered from prior surgery Prior surgical resection for NSCLC allowed Other More than 12 weeks since prior investigational agents and recovered No other concurrent specific antitumor therapy No other concurrent investigational agents
Sites / Locations
- Institute of Clinical Research - BirminghamRecruiting
- Birmingham Heartlands HospitalRecruiting