EUCTR2005-001463-64-SE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 #05, incorporating Protocol Amendments 04, 07, 08 and 10;+ Pharmacokinetics Blood Sample Amendment #03 dated 18-Oct-05+ Amendment #06, dated 24-Feb-06
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
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 (+ 2 weeks) 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 2 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 or T1b, Gleason score = 6, PSA < 0.5 ng/ml) or in-situ cervical carcinoma or any other tumor with a disease-free interval = 5 years (4.5 years per prior BMS Medical Monitor approval).
- •5) Prior discontinuation of platinum for reasons of toxicity only.
- •(Note: patients who switch platinum therapy due to toxicity are eligible if he/she does not progress between platinum agents and the two courses of therapy are considered one treatment regimen.)
- •6) Receipt of more than one prior chemotherapy regimen in any setting (Note: sequential regimens allowed).
- •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 major 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.
- •20) Sexually active fertile men not using effective birth control during the study and up to 6 months after the study if their partners are women of child-bearing potential.
- •21) Women who are pregnant or breastfeeding
- •22) Women with a positive pregnancy test on enrollment or prior to study drug administration.
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