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临床试验/EUCTR2005-001463-64-AT
EUCTR2005-001463-64-AT进行中（未招募）不适用

A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the UrotheliumRevised Protocol #01, version 2.0 incorporating Protocol Amendment #04, andPharmacogenetics Blood Sample Amendment #01, dated 18-Oct-04Primary Tumor Tissue Sample Amendment #02, dated 18-Oct-04Pharmacokinetics Blood Sample Amendment #03, dated 18-Oct-04

Bristol-Myers Squibb International Corporation0 个研究点目标入组 150 人开始时间: 2005年9月6日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
150
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •1) Provided signed written informed consent.
  • •2) Histologic diagnosis of predominantly locally advanced or metastastic transitional
  • •cell carcinoma (TCC) of the urothelium (urinary bladder, kidney, renal pelvis, or
  • •ureter) (NOTE: rare foci of other histologies are acceptable).
  • •3) At the time of study entry, patient must no longer be a candidate for local/regional
  • •control of disease (surgery and/or radiotherapy, see Protocol Appendix 1 for reference).
  • •4) Patients must have received at least two cycles of prior cisplatin at a dose of least
  • •60 mg/m2 or prior carboplatin at a dose of at least AUC 4 (or equivalent) in any
  • •setting. (NOTE: subsequent cycles of cisplatin or carboplatin, if delivered, need not
  • •be 60 mg/m2 or AUC 4, respectively).
  • •5) Measurable disease documented by imaging with at least one bidimensional lesion
  • •(See Protocol Section 3.3.2)
  • •6) Documented relapse or progressive disease within 12 months after the last dose of a platinum containing regimen in any setting at the time of study entry.
  • •7) Karnofsky Performance Status of 100, 90, or 80 (See Protocol Appendix 2)
  • •8) Recovery from toxicity due to prior therapy (i.e. toxicity has resolved to baseline or is deemed irreversible). At least 4 weeks must have elapsed since last dose of chemotherapy (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin),
  • •immunotherapy, or radiotherapy and the beginning of protocol therapy.
  • •9) Men and women = age 18
  • •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
  • •25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study
  • •medication.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 12 weeks after the study.
  • •2) WOCBP using a prohibited contraceptive method.
  • •3) Diagnosis of predominantly non-transitional cell carcinoma of the urothelium
  • •(adenocarcinoma, squamous cell carcinoma, small cell, or other).
  • •4) Diagnosis of other malignancies except adequately treated basal cell carcinoma of the skin, incidental prostate cancer (T1a, Gleason score 6, PSA < 0.5 ng/ml) or in-situ cervical carcinoma or any other tumor with a disease-free interval = 5 years.
  • •5) Prior discontinuation of platinum for reasons of toxicity only.
  • •6) Receipt of more than one prior chemotherapy regimen in any setting.
  • •7) Known brain metastases or leptomeningeal involvement. CT scans are not required to rule this out unless there is clinical suspicion of central nervous system (CNS) disease.
  • •8) CTC (v.2.0) = Grade 2 peripheral neuropathy.
  • •9) Prior radiation to = 30% of the bone marrow. (See Protocol Appendix 3)
  • •10) A serious uncontrolled medical disorder, recent abdominal surgery or active infection which would impair the ability of the patient to receive protocol therapy
  • •11) Concurrent heart failure (New York Heart Association Class III - IV) or unstable
  • •angina, myocardial infarction within the prior 6 months, or poorly controlled hypertension
  • •12) Psychological, familial, or sociological conditions that do not permit medical
  • •follow-up and/or compliance with the study protocol.
  • •13) Inadequate hematologic function defined by an absolute neutrophil count (ANC)
  • •< 1,500 cells/mm3 or a platelet count < 100,000 cells/mm3.
  • •14) Inadequate hepatic function defined by a total bilirubin level > 1.5 times the upper limit of normal (ULN) or transaminases (ALT, AST) level > 2.5 times the ULN
  • •(> 5 times the ULN only in case of liver metastasis).
  • •15) Inadequate renal function defined by a serum creatinine clearance < 40 ml/min
  • •(Cockcroft-Gault formula, see Protocol Appendix 4).
  • •16) Prior allergic reaction to any vinca alkaloid.
  • •17) Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir and indinavir.
  • •18) Any concurrent chronic systemic immune therapy (including steroids), chemotherapy, radiation therapy, hormonal therapy (except for physiologic replacement), or any other investigational agent.
  • •19) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

研究者

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