Status:
COMPLETED
Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Transitional Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 standar...
Eligibility Criteria
Inclusion
- 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
- 74 mmol/L\<\[Mg2+\] \<1.03 mmol/
- 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
- 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:
- Uncontrolled infection (active serious infections that are not controlled by antibiotics)
- Peripheral neuropathy grade 2 or higher (by NCI common toxicity criteria in sensory or motor neuropathy)
- Clinically significant arrhythmia (electrocardiogram QTc greater than 500 msec)
- 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)
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00173862
Start Date
May 1 2000
End Date
June 1 2006
Last Update
July 25 2007
Active Locations (1)
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1
Department of Oncology , National Taiwan University Hospital
Taipei, Taiwan, 100