Weekly TP-HDFL in the Treatment of Advanced TCC

Phase 2

Completed

• Conditions: Transitional Cell Carcinoma
• Interventions: Drug: Paclitaxel, Cisplatin, 5-Fluorouracil

• Registration Number: NCT00154687
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Study Start: 2000-10
• Study Completion: 2004-12
• Status Verified: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Last Update Submitted: 2007-07-30
• Last Update Posted: 2007-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Paclitaxel, Cisplatin, 5-Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
response rate	2000~2005

Secondary Outcome Measures

Name	Time	Method
Overall Survival ,Safety	2000~2005

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan