Lung Cancer
Conditions
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
Brief 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.
Detailed description
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.
Interventions
DRUGpaclitaxel
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Countries
Belgium, Czechia, Germany, Italy, Netherlands
Outcome results
None listed