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 人开始时间: 2014年10月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
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)
- •*Platelet count greater than or equal to 90 x10^9/L (100,000/mm3)
- •*Hemoglobin greater than or equal to 90 g/L
- •*Calculated creatinine clearance greater than 25 mL/min (Cockcroft and Gault formula)
- •*Total bilirubin less than or equal to 1.5 times the upper limit of normal (less than or equal to 2.5X if Gilbert's disease)
- •*ALT (SGPT) less than or equal to 3 x ULN or less than or equal to 5 x ULN if hepatic metastases are present
- •6. Patients may have had prior neoadjuvant or adjuvant therapy for completely resected disease, provided it was completed at least 12 months prior to randomization. Patients must have recovered from any acute toxic effects to less than or equal to Grade 2 from any prior treatments. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line therapy in the metastatic setting if the patient progressed within 12 months of the last dose.
- •7. Patients must have received one and only one prior chemotherapeutic regimen which included a platinum (at least one cycle) for metastatic/recurrent disease. Treatment must have been discontinued at least 4 weeks prior to randomization in this study. Patients must have recovered from any acute toxic effects to less than or equal to Grade 2 from any prior treatments
- •8. Patients may not have had any prior therapy with a taxane in any setting.
- •9. Patients may have had prior investigational agents but these must have been discontinued at least 4 weeks prior to randomization. Patients must have recovered from any acute toxic effects less than or equal to Grade 2 from any prior treatments.
- •10. Prior treatments with radiation therapy in the adjuvant and/or metastatic setting are permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy and all treatment related adverse events are less than or equal to Grade 1 at the time of randomization.
- •11. Patients may have had prior surgery provided that at least 4 weeks elapsed between the end of surgery and randomization onto the study. Patients must have recovered from any acute toxic effects less than or equal to Grade 2 from any prior treatments.
- •12. Patients may have peripheral neuropathy from previous treatments assuming it is less than or equal to Grade 2.
- •13. Patient is able (i.e. sufficiently fluent) and willing to complete the health and demographic,
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.
- •3. Any evidence of severe or uncontrolled systemic diseases which include known cases of hepatitis B or C or human immunodeficiency virus (HIV). Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. Screening for chronic conditions is not required, although patients known to have such conditions at screening should not be included.
- •4. Women who are pregnant or breastfeeding.
- •5. Patients with history of allergic or hypersensitivity reactions to any study drug or their excipients or with a history of allergic reactions attributed to compounds with similar chemical composition to any of the study drugs.
- •6. Planned concomitant participation in another clinical trial of an experimental agent, vaccine or device. Concomitant participation in observational studies is acceptable.
- •7. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than or equal to 5 years. Prior prostate cancer is allowed provided that it is an incidental finding at cystoprostatectomy with a PSA of less than 0.5 ng/mL at randomization or a prior diagnosis of low risk prostate cancer at any time as defined by less than or equal to T2, a Gleason Score of 6 or less and PSA of less than 10 ng/mL.
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