ISRCTN54607216已完成2 期
A phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advanced transitional carcinoma of the urothelium
Cardiff University (UK)0 个研究点目标入组 63 人开始时间: 2008年4月25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
- 63
研究概览
简要总结
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25465968 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 18 years, either sex
- •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 (T4b Nany Many, Tany N2-3 Many or Tany Nany M1) not amenable to curative treatment with surgery or radiotherapy
- •4. Estimated life expectancy greater than three months
- •5. World Health Organization (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 four cycles), completed at least six months prior to first documented disease progression will remain eligible
- •8. No prior radiotherapy within one month prior to registration or involving more than 30% of total bone marrow volume
- •9. No investigational drug within one month prior to registration
- •10. Adequate renal function (glomerular filtration rate [GFR] greater than 60 ml/min, uncorrected for surface area and measured by isotopic means
- •11. Adequate bone marrow function (absolute neutrophil count greater than or equal to 1.5 x 10^9/l; platelets greater than or equal to 100 x 10^9/l at baseline)
- •12. Adequate liver function (bilirubin less than or equal to 1.5 x upper limit of normal [ULN]; alanine aminotransferase [ALT] and alkaline phosphatase [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
排除标准
- •1. Patients with transitional cell 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 central nervous system (CNS) metastases - routine baseline computed tomography (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. Woman of childbearing potential must have a negative pregnancy test performed within seven 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 six months, congestive cardiac failure greater than New York Heart Association [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 medication which have adverse interactions with sunitinib
研究者
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