Overview

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

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
0
Participant gender:
All
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 .
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Cisplatin
Gemcitabine
Ifosfamide
Isophosphamide mustard
Criteria
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)