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Weekly TP-HDFL in the Treatment of Advanced TCC

NCT ID: NCT00154687

Last Updated: 2007-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Transitional Cell Carcinoma

Keywords

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Combination, Chemotherapy,transitional cell carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Paclitaxel, Cisplatin, 5-Fluorouracil

Intervention Type DRUG

Interventions

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Paclitaxel, Cisplatin, 5-Fluorouracil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Chih-Hung Hsu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology , National Taiwan University Hospital

Ann-Lii Cheng, M.D.,Ph.D

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

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Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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159I3

Identifier Type: -

Identifier Source: org_study_id