Weekly TP-HDFL in the Treatment of Advanced TCC

A Phase II Study of Weekly Paclitaxel, Cisplatin and 24-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin(Weekly TP-HDFL) in the Treatment of Advanced Transitional Cell Carcinoma(TCC)

The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.

Transitional cell carcinoma(TCC)of urothelium,including bladder, ureter, and renal pelvis TCCs, was the most lethal urology malignancy in Taiwan. In 1995, approximately 1,300 new cases of TCC was diagnosed in Taiwan and more than 600 patients died of this disease. Advanced TCC is a moderately chemosensitive disease. A combination of methotrexate, vinblastine, and cisplatin with or without doxorubicin (M-VAC or CMV) has been widely used since 1980s. Despite the response rate was as high as 40-70%, the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy. One of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy.

Inclusion Criteria: Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC Measurable disease Age>18 KPS>60﹪ Creatinine clearance>35ml/min, AST/ALT < or = 3.5times upper limits of normal reference values Bilirubin< or = 2.0 mg/dl WBC > or = 4,000/mm3, PLT > or = 100,000/mm3 Written informed consent Exclusion Criteria: Previous systemic chemo is not allowed TG <70mg/dl CNS metastasis Life expectancy less than 3 months