Weekly TP-HDFL in the Treatment of Advanced TCC

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Paclitaxel, Cisplatin, 5-Fluorouracil