Phase II Study on TAXOL in Bronchioalveolar Carcinoma

Date de début de l'étude : 1 janvier 1997

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