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A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Transitional Cell Carcinoma

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Trial Information

A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma

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.

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

1. Uncontrolled infection (active serious infections that are not controlled by

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:


Principal Investigator

Chih-Hung Hsu, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology , National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

May 2000

Completion Date:

June 2006

Related Keywords:

  • Transitional Cell Carcinoma
  • Combination, Chemotherapy,transitional cell carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell