Weekly TP-HDFL in the Treatment of Advanced TCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154687
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 31, 2007
Information provided by:
National Taiwan University Hospital

September 8, 2005
September 12, 2005
July 31, 2007
October 2000
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response rate [ Time Frame: 2000~2005 ]
response rate
Complete list of historical versions of study NCT00154687 on Archive Site
Overall Survival ,Safety [ Time Frame: 2000~2005 ]
Overall Survival ,Safety
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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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Transitional Cell Carcinoma
Drug: Paclitaxel, Cisplatin, 5-Fluorouracil
Experimental: A
Intervention: Drug: Paclitaxel, Cisplatin, 5-Fluorouracil
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2004
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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National Taiwan University Hospital
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Principal Investigator: Chih-Hung Hsu, M.D.,Ph.D. Department of Oncology , National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, M.D.,Ph.D Department of Oncology, National Taiwan University Hospital
National Taiwan University Hospital
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP