A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer

Date de début de l'étude : 1 août 1999

DISEASE CHARACTERISTICS: Histologically confirmed stage IV locally advanced or metastatic transitional cell carcinoma of the urothelium that is not amenable to curative surgery or radiotherapy T4b or N2 or N3 or M1 No pure adenocarcinomas, pure squamous carcinomas, or small cell carcinoma Evaluable or bidimensionally measurable disease If only single lesion, must not be within portal of prior irradiation No active CNS metastases Adequately treated CNS metastases eligible provided stable for 8 weeks following therapy and no longer requires steroids or antiseizure medication No clinically significant pleural effusions or ascites unless drained prior to administration of methotrexate PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-1 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled cardiac disease (e.g., congestive heart failure, arrhythmia, or angina) Pulmonary: No uncontrolled pulmonary disease (e.g., chronic obstructive pulmonary disease) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No concurrent active infection No known hypersensitivity to docetaxel, methotrexate, cisplatin, gemcitabine, filgrastim (G-CSF), oprevelkin, or any component of these products No serious concurrent medical disorder No medical or psychiatric conditions that would compromise consent or preclude completion of study No other malignancy within the past 3 years except: Carcinoma in situ of the cervix Adequately treated nonmelanoma skin cancer Stage I or II prostate cancer provided adequate local therapy (surgery or radiation) has been administered and PSA is less than 1.0 ng/mL No preexisting peripheral neuropathy grade 2 or greater PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy for metastatic disease At least 6 months since prior neoadjuvant or adjuvant chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior major surgery and recovered Other: No other concurrent investigational drugs