NCT01196559已完成2 期
A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Objective response rate (complete response and partial response)
研究概览
简要总结
The purpose of this study is to evaluate the objective response rate and safety in platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients treated with vinorelbine and gemcitabine combination chemotherapy.
详细描述
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must sign an approved informed consent form (ICF)
- •Histologically or cytologically confirmed epithelial ovarian/fallopian tube/primary peritoneal carcinoma
- •Patients had to have received a front-line, platinum/taxane based chemotherapy regimen
- •Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer or progressed within six months of completing the most recent platinum-based chemotherapy
- •Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 3 prior systemic cytotoxic regimens.
- •Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area and increased Ca 125
- •A >= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
- •Age 20-75 years old
- •Performance status (WHO) 0-2
- •Life expectancy of at least three months
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl)
排除标准
- •prior therapy with vinorelbine or gemcitabine
- •treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
- •Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure, recent myocardial infarction or active infection.
- •Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
- •Symptomatic central nervous system (CNS) metastasis.
- •Uncontrolled intestinal obstruction
- •Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational
- •Pregnant or nursing.
研究组 & 干预措施
Vinorelbine and Gemcitabine
Experimental
Vinorelbine 25 ㎎/㎡ and Gemcibine1000㎎/㎡ D1, D8 every 3weeks
干预措施: Vinorelbine and Gemcitabine (Drug)
结局指标
主要结局
Objective response rate (complete response and partial response)
时间窗: 16 weeks
radiologically assessed response every two cycles, according to RECIST ver 1.1 criteria and serologically assessed CA 125 response every two cycles, according to Rustin's criteria
次要结局
- Frequency and severity of adverse effects(every cycle , from enrollment until death)
- Progression Free Survival(6months)
- overall survival(1year)
研究者
Sook Hee Hong
Division of Medical Oncology, Multidisciplinary team of Gynecologic cancer, Seoul St. Mary's hospital
The Catholic University of Korea
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Study of Gemcitabine and Vinorelbine in Soft Tissue SarcomasSarcoma, Soft TissueNCT00134641Dana-Farber Cancer Institute40
已完成
2 期
Gemzar, Cisp, Sunitinib Urothelial CaUrothelial CancerNCT00821327US Oncology Research36
已完成
2 期
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal CancerFallopian Tube CancerPeritoneal CancerOvarian CancerNCT00267696Ohio State University Comprehensive Cancer Center45
已完成
1 期
Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder CancerCarcinoma, Transitional CellNCT00101842Eli Lilly and Company61
Unknown
1 期
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard TherapiesPancreatic NeoplasmsNCT00081549Aronex Pharmaceuticals111