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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Centre Hospitalier Regional de la Citadelle
Liege (Luik), Belgium
University Thomayers' Hospital
Krhanice, Czechia
Universitaetsklinik und Strahlenklinik - Essen
Essen, Germany
Azienda Ospedale S. Luigi - Universita Di Torino
Orbassano, (Torino), Italy
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Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands