Weekly TP-HDFL in the Treatment of Advanced TCC

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154687
First received: September 8, 2005
Last updated: July 30, 2007
Last verified: July 2005
  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)

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154687

Locations
Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cisplatin
Fluorouracil
Paclitaxel
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014