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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00173862

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Transitional Cell Carcinoma	Drug: Gemcitabine, Ifosfamide	Phase 2

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2000

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Gemcitabine, Ifosfamide

Arm

Intervention/Treatment

Experimental: A

Drug: Gemcitabine, Ifosfamide

Outcome Measures

Primary Outcome Measures

Response rate [2000~2006]

Secondary Outcome Measures

Overall Survival, Safety [2000~2006]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology , National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

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