Clinical trial NCT00173862: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transitional Cell Carcinoma
Keywords: Combination, Chemotherapy,transitional cell carcinoma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Response rate
timeFrame: 2000~2006
Secondary outcomes:
measure: Overall Survival, Safety
timeFrame: 2000~2006
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology , National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology , National Taiwan University Hospital
name: Chih-Hung Hsu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D., Ph.D.
role: STUDY_CHAIR
References: