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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154687

Enrollment

Registered

2005-09-12

Start date

2000-10-31

Completion date

2004-12-31

Last updated

2007-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transitional Cell Carcinoma

Keywords

Combination, Chemotherapy,transitional cell carcinoma

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.

Interventions

DRUGPaclitaxel, Cisplatin, 5-Fluorouracil

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
response rate	2000~2005

Secondary

Measure	Time frame
Overall Survival ,Safety	2000~2005

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026