Brief Title
Weekly TP-HDFL in the Treatment of Advanced TCC
Official Title
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)
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
response rate
Secondary Outcome
Overall Survival ,Safety
Condition
Transitional Cell Carcinoma
Intervention
Paclitaxel, Cisplatin, 5-Fluorouracil
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
October 2000
Completion Date
December 2004
Eligibility Criteria
Inclusion Criteria: 1. Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC 2. Measurable disease 3. Age>18 4. KPS>60﹪ 5. Creatinine clearance>35ml/min, 6. AST/ALT < or = 3.5times upper limits of normal reference values 7. Bilirubin< or = 2.0 mg/dl 8. WBC > or = 4,000/mm3, PLT > or = 100,000/mm3 9. Written informed consent Exclusion Criteria: 1. Previous systemic chemo is not allowed 2. TG <70mg/dl 3. CNS metastasis 4. Life expectancy less than 3 months
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Chih-Hung Hsu, M.D.,Ph.D., ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT00154687
Organization ID
159I3
Study Sponsor
National Taiwan University Hospital
Study Sponsor
Chih-Hung Hsu, M.D.,Ph.D., Principal Investigator, Department of Oncology , National Taiwan University Hospital
Verification Date
July 2005