Weekly TP-HDFL in the Treatment of Advanced TCC

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

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

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