NCT01815528已完成2 期
Single -Arm, Multicenter Phase-II Trial for Catumaxomab and Chemotherapy in Patients With Recurrent Ovarian Cancer to Investigate the Feasibility and Clinical Activity of Initial Intraperitoneal Catumaxomab Followed by Chemotherapy Regimes
JSehouli1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens
研究概览
简要总结
Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
- •Recurrent ovarian cancer disease
- •Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST
- •Radiologically and cytologically confirmed malignant ascites possible to puncture
- •Life expectancy ≥ 12 weeks
- •Age ≥ 18 years
- •ECOG performance status at least 1
- •No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug
- •Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent
- •Non-childbearing potential or negative pregnancy test
排除标准
- •known brain metastases
- •Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases)
- •Any investigational product within 2 weeks prior to first administration of catumaxomab
- •In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis):
- •not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen)
- •Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab
- •Abnormal organ or bone marrow function
- •Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry
- •Any known active and chronic infection
- •Known HIV infection and / or hepatitis B virus or hepatitis C virus
- •Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
- •Known or suspected hypersensitivity to catumaxomab and its analogues in general or to murine proteins (from rat or mouse)
- •Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients.
- •Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease
- •Body mass index (BMI) < 17 (assessment after ascites drainage)
- •Inadequate respiratory function in the opinion of the investigator
- •Presence of complete bowel obstruction
- •Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements.
- •Unwilling or unable to follow protocol requirements
- •Participation in another clinical study with experimental therapy within 14 days before start of treatment
- •Legal incapacity or limited legal capacity
- •Subjects housed in an institution on official or legal orders
- •Pregnancy or lactation period
研究组 & 干预措施
Catumaxomab
Experimental
Catumaxomab treatment followed by an established chemotherapy regimen
干预措施: Catumaxomab (Drug)
结局指标
主要结局
Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens
时间窗: Approximately 5 months after start of treatment per patient
Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens defined by rate of patients with at least 4 chemotherapy cycles following 4 applications of catumaxomab within 20 days as described in the scope of this clinical trial.
次要结局
- Number and severity of adverse events as a measure of safety and tolerability(Approximately 2.5 years after start of study)
- Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application(Approximately 2.5 years after start of study)
- Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter)(Approximately 2.5 years after start of study)
- To assess PFS according to RECIST and/or CA-125 response rate, OS(Approximately 2.5 years after start of study)
- Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy(Approximately 2.5 years after start of study)
- To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire(Approximately 2.5 years after start of study)
- Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy(Approximately 2.5 years after start of study)
- Time to progression (TTP) according to RECIST and/or CA-125 response rate(Approximately 2.5 years after start of study)
- Overall response rate (ORR) defined as patients with complete or partial response and duration of response (according to RECIST and/or CA-125 response)(Approximately 2.5 years after start of study)
- To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy(Approximately 2.5 years after start of study)
- Potential predictive clinical factors for response to catumaxomab(Approximately 2.5 years after start of study)
研究者
JSehouli
Prof. Dr. med. Jalid Sehouli
Charite University, Berlin, Germany
研究点 (1)
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