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CompletedNCT00154687Updated Jul 31, 2007

Weekly TP-HDFL in the Treatment of Advanced TCC

A Phase 2 interventional study of Paclitaxel, Cisplatin, 5-Fluorouracil in Transitional Cell Carcinoma, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-07-31.

Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Transitional Cell Carcinoma

Keywords

  • Combination, Chemotherapy,transitional cell carcinoma
03

In context

Carcinoma, Transitional Cell

725 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 556 interventional studies indexed under Carcinoma, Transitional Cell.

Browse Carcinoma, Transitional Cell studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Previous systemic chemo is not allowed
  2. TG \<70mg/dl
  3. CNS metastasis
  4. Life expectancy less than 3 months
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    A

    Drug: Paclitaxel, Cisplatin, 5-Fluorouracil

Interventions

06

What researchers measure

Primary outcomes

  1. response rate

    Time frame: 2000~2005

Secondary outcomes

  1. Overall Survival ,Safety

    Time frame: 2000~2005

07

Study locations

1 site
  • Department of Oncology, National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00154687
First posted
Sep 12, 2005
Start date
Oct 2000
Completion
Dec 2004
Last update
Jul 31, 2007

Study contacts

Chih-Hung Hsu, M.D.,Ph.D.
principal investigator · Department of Oncology , National Taiwan University Hospital
Ann-Lii Cheng, M.D.,Ph.D
study chair · Department of Oncology, National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Paclitaxel · Cisplatin · Fluorouracil

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