Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC

Date de début de l'étude : 1 septembre 1995

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant small cell component. Eligible Stages Include: Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence that is histologically or cytologically proven. CNS Metastases Allowed Provided: Radiotherapy completed prior to entry. No requirement for concurrent steroids. No carcinomatous meningitis. No epidural metastases. Measurable disease not required. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Not specified. Chemotherapy: No prior chemotherapy for lung cancer. Endocrine Therapy: Not specified. Radiotherapy: No prior chest irradiation for lung cancer. Surgery: Prior surgery allowed. PATIENT CHARACTERISTICS: Age: 18 and over. Performance Status: ECOG 0-2. Hematopoietic: Absolute granulocyte count greater than 2,000. Platelet count greater than 100,000. Hepatic: Bilirubin no greater than 1.5 mg/dL. Renal: Creatinine no greater than 1.5 mg/dL. Cardiovascular: No CHF unless fully compensated. No second- or third-degree heart block. No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia. No sustained ventricular tachycardia. No MI within 3 months. OTHER: No uncontrolled infection unless due to an obstructed bronchus. No major psychiatric problems requiring hospitalization. No psychotropic medications such as phenothiazines. No contraindication to transfusion, if required. No second malignancy within 5 years except: Nonmelanomatous skin cancer. In situ cervical cancer. No pregnant or nursing women. Effective contraception required of fertile patients.