EUCTR2007-007591-42-GB进行中（未招募）1 期
A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advancd transitional carcinoma of the urothelium. - SUCCINCT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
入选标准
- •1. Age greater than or equal to 16 years
- •2. Histologically confirmed transitional cell carcinoma (pure or mixed histology) of urothelium (upper or lower urinary tract)
- •3. Radiologically measurable, locally advanced and/or metastatic disease not amenable to curative treatment with surgery
- •or radiotherapy: (a) T4b (bladder) / T4 (renal pelvis / ureter) Nany Many, (b) Tany N2-3 Many, (c) Tany Nany M1
- •4. Estimated life expectancy greater than 3 months
- •5. WHO performance status 0-2
- •6. Fit to receive cisplatin-containing combination chemotherapy
- •7. No prior systemic therapy for locally advanced or metastatic disease - patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to 4 cycles), completed at least 6 months prior to first documented disease progression will remain eligible
- •8. No prior radiotherapy within 1 month prior to registration or involving more than 30% of total bone marrow volume
- •9. No investigational drug within 1 month prior to registration
- •10. Adequate renal function (GFR >60mL/min, uncorrected for surface area and measured by isotopic means)
- •11. Adequate bone marrow function (absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L; Plts greater than or equal to 100 x 109/L at baseline)
- •12. Adequate liver function (Bili less than or equal to 1.5x ULN; ALT and ALP less than or equal to 2.5 ULN at baseline)
- •13. Prothrombin time (PT) or International normalised ratio (INR) less than or equal to 1.5 x ULN
- •14. Written informed consent
- •Are the trial subjects under 18? yes
- •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. Patients with urothelial cancer in whom subsequent radical treatment is being considered with a view to possible cure
- •2. Previous malignancy other than non-melanoma skin cancer, cervical carcinoma in situ or incidental localised prostate cancer
- •3. Previously identified CNS metastases - routine baseline CT scanning of the head is not a requirement for trial entry and should only be performed if clinically indicated
- •4. Women who are pregnant or breast feeding. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of trial therapy
- •5. Men and women not prepared to practice method(s) of birth control of established efficacy
- •6. Known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C
- •7. Uncontrolled hypertension
- •8. Symptomatic coronary artery disease, myocardial infarction within the last 6 months, congestive cardiac failure >NYHA class II, uncontrolled or symptomatic cardiac arrhythmia
- •9. Clinically significant bacterial or fungal infection
- •10. Concurrent anticoagulant therapy with warfarin or un-fractionated heparin - patients requiring anti-coagulation may be entered after successful conversion to low molecular weight heparin (LMWH)
- •11. Concomitant medications which have known adverse interactions with the trial treatment
研究者
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