A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
A
干预措施: Gemcitabine, Ifosfamide (Drug)
结局指标
主要结局
Response rate
时间窗: 2000~2006
次要结局
- Overall Survival, Safety(2000~2006)