EUCTR2005-003733-40-FR进行中（未招募）1 期
A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients who are Ineligible to Receive Cisplatin-Based Therapy - VINCENT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Target population
- •2) Histologic diagnosis of predominantly locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium (urinary bladder, kidney, renal pelvis, or ureter);
- •3) Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions:
- •- Calculated creatinine clearance (Cockroft-Gault formula, see Appendix 3) = 60 mL/min; or,
- •- New York Heart Association Classification Stage III-IV Congestive Heart Failure (see Protocol Appendix 4);
- •4) Measurable disease documented by imaging with at least one uni-dimensional lesion;
- •5) ECOG performance status of 0, 1, or 2 (see Protocol Appendix 5);
- •6) The following laboratory parameters:
- •- Absolute Neutrophil Count = 1,500 mm3,
- •- Platelet count = 100,000 mm3,
- •- Serum total bilirubin = 1.5 x upper limit of normal (ULN),
- •- Transaminases = 2.5 x ULN [> 5 times ULN only in case of liver metastasis].
- •7) If patient received neoadjuvant or adjuvant chemotherapy, he/she must have documented relapse, = 6 months after the last dose of chemotherapy.
- •Age and Sex
- •8) Men and women = age 18 years of age
- •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
- •Sex and Reproductive Status
- •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) Women who are pregnant or breastfeeding.
- •4) Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •5) 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.
- •Target Disease Exceptions
- •6) Diagnosis of predominantly non-transitional cell carcinoma of the urothelium (adenocarcinoma, squamous cell carcinoma, small cell, or other) or TCC originating at sites other than the urothelium.
- •7) Patients in whom radiation or surgery is indicated.
- •Medical History and Concurrent Diseases
- •8) Previous systemic chemotherapy treatment for locally advanced or metastatic disease (intravesical treatment is allowed, as well as neoadjuvant and adjuvant chemotherapy that was completed = 6 months before documented PD).
- •9) Known brain metastases or leptomeningeal involvement. CT scans are not required unless there is clinical suspicion of central nervous system (CNS) disease.
- •10) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
- •CTCAE) (v. 3.0) = Grade 3 peripheral neuropathy.
- •11) Prior radiation to = 30% of the bone marrow (See Protocol Appendix 6).
- •12) Other serious illness or medical condition including:
- •- Infection requiring systemic anti-infective therapy,
- •- any medical condition that might be aggravated by treatment or which could not be controlled, for instance patients with unstable angina, patients with myocardial infarction within 6 months and/or poorly controlled hypertension.
- •13) Other malignancies except adequately treated basal carcinoma of the skin, in-situ prostrate cancer Gleason = 6, in-situ cervix carcinoma or any other tumor with a disease free interval = 5 years.
- •14) Psychological, familial, or sociological conditions which do not permit medical follow-up and/or compliance with the study protocol.
- •Physical and Laboratory Test Findings
- •15) Inadequate renal function defined by a serum creatinine clearance = 20 mL/min (Cockcroft-Gault formula, see Protocol Appendix 3).
- •Allergies and Adverse Drug Reactions
- •16) Prior allergic reaction to any vinca alkaloid.
- •Prohibited Therapies and/or Medications
- •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.
- •Other Exclusion Criteria
- •20) Prisoners or patients who are compulsorily detained
研究者
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