combination chemotherapy in treating patients with advanced 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 carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.

objectives: * determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind. * determine the feasibility and toxicity of this regimen in these patients. * determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen. outline: patients receive gemcitabine iv over 30 minutes on days 1 and 8 and carboplatin iv over 30 minutes on day 1. chemotherapy repeats every 21 days for up to 6 courses. patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs. patients are followed every 3 months for 2 years and then every 6 months for 2 years. projected accrual: a total of 55 patients will be accrued for this study within 6 months.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer (nsclc) * unresectable stage iiib (e.g., pleural effusion) not suitable for combined modality therapy or * stage iv * prior brain metastases are allowed provided the following are true: * patient completed radiotherapy and/or surgery at least 3 weeks prior to study * objective evidence of resolution or significant improvement of brain lesions exists on follow-up ct scan or mri * patient is neurologically improved or stable patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * absolute granulocyte count at least 1,500/mm\^3 * wbc at least 3,000/mm\^3 * hemoglobin at least 9 g/l * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.25 mg/dl * sgot no greater than 1.5 times upper limit of normal renal: * creatinine no greater than 2.0 mg/dl or * creatinine clearance at least 50 ml/min cardiovascular: * no prior uncontrolled cardiovascular disease * no hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective nonhormonal contraception * no serious active infection * no dementia or active psychoses * no other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 3 weeks since prior radiotherapy surgery: * see disease characteristics other: * at least 1 month since prior investigational agents * more than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (cox-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen) * no concurrent sulindac or cox-2 inhibitors

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer