Weekly TP-HDFL in the Treatment of Advanced TCC
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transitional Cell Carcinoma |
Drug: Paclitaxel, Cisplatin, 5-Fluorouracil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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) |
- response rate [ Time Frame: 2000~2005 ]
- Overall Survival ,Safety [ Time Frame: 2000~2005 ]
| Enrollment: | 40 |
| Study Start Date: | October 2000 |
| Study Completion Date: | December 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A | Drug: Paclitaxel, Cisplatin, 5-Fluorouracil |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Taiwan | |
| Department of Oncology, National Taiwan University Hospital | |
| Taipei, Taiwan, 100 | |
| Principal Investigator: | Chih-Hung Hsu, M.D.,Ph.D. | Department of Oncology , National Taiwan University Hospital |
| Study Chair: | Ann-Lii Cheng, M.D.,Ph.D | Department of Oncology, National Taiwan University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00154687 History of Changes |
| Other Study ID Numbers: | 159I3 |
| Study First Received: | September 8, 2005 |
| Last Updated: | July 30, 2007 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Combination, Chemotherapy,transitional cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Cisplatin Fluorouracil Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013