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

Primary Purpose

Transitional Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Gemcitabine, Ifosfamide
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transitional Cell Carcinoma focused on measuring Combination, Chemotherapy,transitional cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Oncology , National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Overall Survival, Safety

Full Information

First Posted
June 30, 2005
Last Updated
July 23, 2007
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00173862
Brief Title
Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC
Official Title
A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Cell Carcinoma
Keywords
Combination, Chemotherapy,transitional cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Ifosfamide
Primary Outcome Measure Information:
Title
Response rate
Time Frame
2000~2006
Secondary Outcome Measure Information:
Title
Overall Survival, Safety
Time Frame
2000~2006

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Hung Hsu, M.D., Ph.D.
Organizational Affiliation
Department of Oncology , National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology , National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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