ACTRN12614001079639
已完成
2 期
A Multicentre Randomized Phase II Trial in Patients With Advanced Urothelial Cancer Progressing on or After a Platinum Containing Regimen with two parallel arms Comparing the effectiveness of Nab-Paclitaxel to Paclitaxel to treat this disease.
HMRC CTC (National Health and Medicine Research Council Clinical Trial Centre) at the University of Sydney.0 个研究点目标入组 199 人2014年10月9日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Advanced Urothelial Cancer
- 发起方
- HMRC CTC (National Health and Medicine Research Council Clinical Trial Centre) at the University of Sydney.
- 入组人数
- 199
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Histologically or cytologically confirmed diagnosis of TCC of the urinary tract (bladder, urethra, ureter, renal pelvis) and metastatic or locally advanced inoperable disease extent (T4, N2, N3 or M1 disease)
- •Note: Mixed histologies (except small cell) permitted if predominately TCC by IHC.
- •2\. Patients must have evidence of metastatic disease, but measurable disease is not mandatory. To be considered evaluable for the overall response rate (complete and partial response), patients must have at least one measurable lesion as follows:
- •\*X\-ray, physical exam greater than or equal to 20 mm
- •\*Conventional CT scan, MRI greater than or equal to 20 mm
- •\*Spiral CT scan greater than or equal to 10 mm
- •3\. Male or female, 18 years of age or older.
- •4\. ECOG performance status less than or equal to 2 at study entry
- •5\. Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to randomization. If anemic, patients should be asymptomatic and should not be decompensated.
- •\*Absolute neutrophil count (ANC) greater than or equal to 1\.5 x10^9/L (1,500 cells/mm3\)
排除标准
- •Exclusion Criteria:
- •1\. A candidate for potentially curative surgery or radiotherapy.
- •2\. Patients with brain metastases are ineligible if they meet at least one of the following criteria:
- •a.diagnosis within 3 months from randomization
- •b.untreated brain metastases
- •c.unstable brain metastasis as defined by:
- •\*cavitation or hemorrhage in the brain lesion
- •\*symptomatic state
- •\*daily prednisone or equivalent use greater than 10 mg
- •Patients do not need CT/MRI scans to rule out brain metastases unless there is a clinical suspicion of CNS metastases.
结局指标
主要结局
未指定
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