Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed 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: NCT00173862
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 25, 2007
Information provided by:
National Taiwan University Hospital

June 30, 2005
September 15, 2005
July 25, 2007
May 2000
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Response rate [ Time Frame: 2000~2006 ]
Response rate
Complete list of historical versions of study NCT00173862 on Archive Site
Overall Survival, Safety [ Time Frame: 2000~2006 ]
Overall Survival, Safety
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Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC
A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as second line chemotherapy in advanced transitional cell carcinoma in terms of response rate and overall survival .

Cisplatin-based combination chemotherapy produces a response rate of 40-70% in TCC patients. However, only less than 10% of the patients can achieve long-term remission. Until now, there is no standard chemotherapy for cisplatin-failed TCC patients. Both gemcitabine and ifosfamide have been identified to have response rates of 20% or more in pretreated TCC patients. It is thus reasonable to combine these two active drugs as a second-line treatment for TCC.

Patients enrolled must have a pathologically proven urothelial transitional cell carcinoma (TCC) and must have exposed to one cisplatin-based combination chemotherapy for the advanced disease. GI regimen will be continued until maximal response.

Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Transitional Cell Carcinoma
Drug: Gemcitabine, Ifosfamide
Experimental: A
Intervention: Drug: Gemcitabine, Ifosfamide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2006
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Inclusion Criteria:

  • Histologically or cytologically confirmed transitional cell carcinoma
  • Advanced / metastatic disease failed to prior chemotherapy (diagnostically confirmed disease progression during the treatment of last chemotherapy or within 6 months after the end of last chemotherapy)
  • Presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ³ 20 mm with conventional technique or ³ 10 mm with spiral CT scan
  • Performance status of ECOG 0, 1, 2
  • Age 20 years or older
  • Life expectancy more than 3 months
  • Adequate hematopoietic function as defined below:

    • WBC ³ 3,000/uL
    • Platelets ³ 75,000/Ul
  • Adequate organ function as defined below:

    • Total bilirubin £ 1.5 ´ ULN
    • ALT / AST£ 5 ´ ULN
    • Creatinine £ 1.5 mg/dL
  • Adequate serum electrolyte concentration:

    • 4 mmol/L<[K+] <5.3 mmol/L
    • 0.74 mmol/L<[Mg2+] <1.03 mmol/
    • 2.02 mmol/L<[Ca2+]<2.60 mmol/L
  • Result of ECG assessment: QTC < 460 msec
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Received chemotherapy, radiotherapy, surgery, or other investigational drug within 4weeks prior to entering the study
  • Receiving other concurrent palliative chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
  • Presence of CNS metastasis
  • Previous or current malignancy with the exception of curatively treated non- melanoma skin cancer or cervical carcinoma in situ
  • Presence of serious concomitant illness which might be aggravated by study medication:

    1. Uncontrolled infection (active serious infections that are not controlled by antibiotics)
    2. Peripheral neuropathy grade 2 or higher (by NCI common toxicity criteria in sensory or motor neuropathy)
    3. Clinically significant arrhythmia (electrocardiogram QTc greater than 500 msec)
    4. Prior myocardial infarction or serious coronary arterial disease within the last 12 months
  • Mental status is not fit for clinical trial.
  • Women of child-bearing potential (pregnancy or breast feeding)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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National Taiwan University Hospital
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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
National Taiwan University Hospital
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP