A Phase II of Intraperitoneal Catumaxomab as a Consolidation Therapy in Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma in Second or Third Complete Clinical Disease Remission
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 17
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of catumaxomab as consolidation treatment in patients with epithelial ovarian cancer in second or third complete remission.
详细描述
Epithelial ovarian cancer is the most lethal malignant gynecological tumor and the fourth most common cause of death by cancer among women. The highest incidence rates are observed in Eastern and Northern Europe, and in the United Status. In Spain, 3,262 new cases were diagnosed in 2002, and the figure is expected to rise to 3,722 cases in 2015 (Globocan 2002, International Agency for Research on Cancer -IARC).
The majority of patients with ovarian cancer are diagnosed at an advanced stage, and are treated with maximum cytoreductive surgery followed by intraperitoneal and/or intravenous chemotherapy. What is considered standard chemotherapy consists of a platinum (carboplatin or cisplatin) combined with a taxane, usually paclitaxel (Ozols, 2003; Armstrong 2006). Although many patients respond to the initial treatment, the majority experience subsequent recurrence of the disease, which is why they need to be treated with successive salvage therapies in an attempt to control the disease until it is converted into totally refractory (Markman, 2004). Only 20-30% of patients can be cured with current treatments, which is why it is necessary to investigate and develop new treatments and/or treatment strategies (Yap, 2009).
Although with the initial treatment based on cytoreductive surgery and platinum-based chemotherapy the large majority of patients achieve complete remission of the disease, 90% of the patients with sub-optimum cytoreductive surgery and 70% with optimum cytoreductive surgery develop a recurrence in the first 24 months. One of the treatment strategies being investigated to try and improve the results is the administration of consolidation or maintenance treatment to those patients that have achieved a complete response of their disease to reduce the risk of subsequent recurrence (Sabbatini, 2006).
In the last few years, various studies have established that investigating a possible therapeutic effect of consolidation or maintenance treatment following second or third complete clinical remission, obtained with a salvage chemotherapy, produces several advantages over the same strategy applied on a first complete clinical response: the median of progression-free survival after second or third complete response is shorter and more predictable -10 months-, and moreover the recurrence is practically universal (Markman 2004; Harrison, 2007; Levine, 2007; Markman, 2008; Juretza, 2008).
Catumaxomab has proven to be effective in patients with refractory tumours and recurring malignant ascites, i.e. patients with a very advanced disease, a large tumour and no treatment options. These clinical conditions are the worst for researching into any immune-based therapy, hence it seems logical to study the efficacy of catumaxomab in more favourable conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Signed Informed consent.
- •Initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma
- •Women ≥ 18 years
- •ECOG performance status ≤ 1 (Eastern Cooperative Oncology Groupperformance)
- •Initial surgical cytoreduction as primary treatment combinated with Platinum- based chemotherapy administered as part of primary therapy.
- •Failure of the primary treatment as manifested by recurrent disease that have achieved a second or third complete response with a second or third-line chemotherapy (platinum-based or not).
- •The complete response to the second or third-line chemotherapy is defined as non symptoms of cancer persistence, normal CA-125 (cancer antigen 125), negative medical examination, and no evidence of disease in a TAC.
- •At least 4 cycles of second or third-line chemotherapy must have been administered
- •Surgery performed at first or second relapse in conjunction with second or third-line chemotherapy is permitted.
排除标准
- •Acute or chronic infection
- •Concomitant treatment with cancer chemo- and/or radiotherapy
- •Exposure to an investigational product within 28 days of first infusion
- •Previous treatment with murine monoclonal antibodies
- •Inadequate renal function: creatinine >1.5 upper limit of normal [ULN] and/ or calculated creatinine clearance ≥ 50 mL/min
- •Inadequate hepatic function (AST, ALT, >2.5 xULN; bilirubin >1.5 xULN), Hypoalbuminaemia < 3 g/dL
- •Platelets <80000 cells/mm3; absolute neutrophil count (ANC) <1000 cells/mm3,
- •Hb < 8g/dL and PTT > 2 x ULN
- •Patients with occlusive intestinal or symptomatic sub-occlusive intestinal within the last 30 days.
- •Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
- •Unable or unwilling to comply fully with the protocol.
- •Any co-morbid disease that would increase risk of toxicity according to investigator judgment
- •Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
- •Exposure to investigational product, cancer, chemo-or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C) before first infusion
- •Known or suspected hypersensitivity to catumaxomab or similar antibodies
- •Long-lasting steroid treatment (≥ 7 days), Patients should only be included after stepwise discontinuation and free of steroids for a minimum of 5 days
研究组 & 干预措施
Catumaxomab
干预措施: Catumaxomab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 3 years
Progression-free survival per protocol is defined as the period from the commencement of the consolidation treatment (catumaxomab Day 0) and the recurrence of the disease or the last follow-up for the patients not developing a recurrence.
次要结局
- Second progression-free survival (2PFS)(3 years)
- Third progression-free survival (3PFS)(3 years)
- Progression-free survival per protocol(3 years)
- First progression-free survival(3 years)
- Duration of the treatment-free interval(3 years)
- Overall survival rate(3 years)
- Incidence, intensity and causalidad of every adverse event.(3 years)
- Therapeutic compliance(3 years)
- The level of cells involved in the immune response(3 years)
- Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab(3 years)
研究者
Secretaría Técnica GEICO
Antonio Gonzalez (Chairman GEICO)
Grupo Español de Investigación en Cáncer de Ovario