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Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173862
First received: June 30, 2005
Last updated: July 23, 2007
Last verified: June 2005

June 30, 2005
July 23, 2007
May 2000
Not Provided
Response rate [ Time Frame: 2000~2006 ]
Response rate
Complete list of historical versions of study NCT00173862 on ClinicalTrials.gov Archive Site
Overall Survival, Safety [ Time Frame: 2000~2006 ]
Overall Survival, Safety
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Transitional Cell Carcinoma
Drug: Gemcitabine, Ifosfamide
Experimental: A
Intervention: Drug: Gemcitabine, Ifosfamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2006
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00173862
155I1
No
Not Provided
National Taiwan University Hospital
Not Provided
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