paclitaxel in treating patients with 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. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage iiib, stage iv or recurrent lung cancer.

objectives: * assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (bac). * assess the duration of response in patients presenting with an objective response. * characterize the acute side effects of paclitaxel in patients with bac. * assess the role of some biological parameters in the natural history and the response to therapy of bac; evaluate the expression of ki67, p53, and k-ras mutation. outline: this is an open label, nonrandomized, multicenter study. paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur. disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs. projected accrual: 16 or 25 patients will be accrued.

Eligibility criteria:
disease characteristics: * histologically proven bronchoalveolar carcinoma (bac) based on these criteria: * absence of primary adenocarcinoma elsewhere * absence of a demonstrable central bronchogenic origin * a peripheral location in the lung parenchyma * intact interstitial framework of the lung * a histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture * must be unresectable stage iiib, iv, or recurrent bac * evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe) * at least one target lesion bidimensionally measurable that has not undergone prior irradiation * no cns disease patient characteristics: age: * 18 to 75 (inclusive) performance status: * ecog 0-2 life expectancy: * greater than 3 months hematopoietic: * anc at least 1,500/mm\^3 hepatic: * bilirubin less than 2 times upper limit of normal * sgot, sgpt, and alkaline phosphatase less than 2 times upper limit of normal renal: * creatinine less than 1.5 times upper limit of normal cardiovascular: * no history of ischemic or congestive heart disease * no arrhythmia requiring chronic cardiopulmonary medications * no history of clinically or electrographically documented myocardial infarction other: * no preexisting motor or other serious sensory neurotoxicity * no active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix * no clinical evidence of uncontrolled infection * not pregnant or nursing * negative pregnancy test 72 hours prior to start of study medication * adequate contraception required of all fertile patients prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since radiotherapy * must have at least one bidimensional lesion outside the irradiated fields surgery: * fully recovered from any prior major surgery

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