Weekly TP-HDFL in the Treatment of Advanced TCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154687
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 31, 2007
Information provided by:
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Transitional Cell Carcinoma Drug: Paclitaxel, Cisplatin, 5-Fluorouracil Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : October 2000
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Paclitaxel, Cisplatin, 5-Fluorouracil

Primary Outcome Measures :
  1. response rate [ Time Frame: 2000~2005 ]

Secondary Outcome Measures :
  1. Overall Survival ,Safety [ Time Frame: 2000~2005 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154687

Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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 Identifier: NCT00154687     History of Changes
Other Study ID Numbers: 159I3
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 31, 2007
Last Verified: July 2005

Keywords provided by National Taiwan University Hospital:
Combination, Chemotherapy,transitional cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs