docetaxel and cisplatin in treating patients with untreated stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage iiia non-small cell lung cancer.

objectives: * assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage iiia non-small cell lung cancer. * determine the safety of this regimen in these patients. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour on day 1 and cisplatin iv over 30 minutes on days 1 and 2. treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. patients are followed for survival. projected accrual: a total of 24-40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage iiia non-small cell lung cancer (nsclc) (t1-3, n2, m0) * unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes * measurable disease * must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral ct scan * no distant metastases * no cns involvement * no pleural or pericardial effusion patient characteristics: age: * over 18 performance status: * who 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than upper limit of normal (uln) * ast/alt no greater than 1.5 times uln * alkaline phosphatase no greater than 2.5 times uln renal: * creatinine no greater than 1.25 uln * creatinine clearance at least 60 ml/min cardiovascular: * no superior vena cava syndrome * no uncontrolled congestive heart failure or angina * no myocardial infarction within past year * no uncontrolled hypertension or arrhythmia other: * not pregnant or nursing * fertile patients must use effective contraception * no concurrent active infection requiring iv antibiotic therapy * no other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma * no concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus) * no motor or sensory neurotoxicity of grade 2 or greater * no psychological, familial, sociological, or geographical condition that would preclude study prior concurrent therapy: biologic therapy: * no concurrent immunotherapy chemotherapy: * no prior chemotherapy for nsclc * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy radiotherapy: * no prior radiotherapy for nsclc * no concurrent radiotherapy surgery: * no prior surgery for nsclc other: * at least 1 month since prior investigational agents * no other concurrent experimental medications

Keywords: stage iiia non-small cell lung cancer