Weekly TP-HDFL in the Treatment of Advanced TCC

Transitional Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154687
• Other study ID #: 159I3
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: July 30, 2007
• Start date: October 2000
• Est. completion date: December 2004

Study information

• Verified date: July 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma

Intervention

Drug:
• Paclitaxel, Cisplatin, 5-Fluorouracil

Locations

Country	Name	City	State
Taiwan	Department of Oncology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		2000~2005
Secondary	Overall Survival ,Safety		2000~2005