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Completed

NCT Number: NCT00154687

Weekly TP-HDFL in the Treatment of Advanced TCC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC
  • Measurable disease
  • Age>18
  • KPS>60﹪
  • Creatinine clearance>35ml/min,
  • AST/ALT < or = 3.5times upper limits of normal reference values
  • Bilirubin< or = 2.0 mg/dl
  • WBC > or = 4,000/mm3, PLT > or = 100,000/mm3
  • Written informed consent

Exclusion criteria

  • Previous systemic chemo is not allowed
  • TG <70mg/dl
  • CNS metastasis
  • Life expectancy less than 3 months

Treatment and study plan

Paclitaxel, Cisplatin, 5-Fluorouracil

Drug

Primary outcomes

  1. response rate

    Time frame: 2000~2005

Secondary outcomes

  1. Overall Survival ,Safety

    Time frame: 2000~2005

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2000
Study completion
2004
First posted
Sep 12, 2005
Registry last updated
Jul 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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