Weekly TP-HDFL in the Treatment of Advanced TCC

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National Taiwan University

Status and phase

Completed
Phase 2

Conditions

Transitional Cell Carcinoma

Treatments

Drug: Paclitaxel, Cisplatin, 5-Fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT00154687
159I3

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 1 patient group

A
Experimental group
Treatment:
Drug: Paclitaxel, Cisplatin, 5-Fluorouracil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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