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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Secondary Outcome
Overall Survival, Safety
Condition
Transitional Cell Carcinoma
Intervention
Gemcitabine, Ifosfamide
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
18
Start Date
May 2000
Completion Date
June 2006
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: 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Chih-Hung Hsu, M.D., Ph.D., ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT00173862
Organization ID
155I1
Study Sponsor
National Taiwan University Hospital
Study Sponsor
Chih-Hung Hsu, M.D., Ph.D., Principal Investigator, Department of Oncology , National Taiwan University Hospital
Verification Date
June 2005