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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Transitional Cell Carcinoma

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Trial Information

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)


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:



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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

2000~2005

Principal Investigator

Chih-Hung Hsu, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology , National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

159I3

NCT ID:

NCT00154687

Start Date:

October 2000

Completion Date:

December 2004

Related Keywords:

  • Transitional Cell Carcinoma
  • Combination, Chemotherapy,transitional cell carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell

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