Phase II Study of Four Dose Levels of Intraperitoneal NanoPac® Plus IV Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- Treatment-emergent Adverse Events
研究概览
简要总结
This study will evaluate NanoPac® administered intraperitoneally (IP) immediately post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with SOC IV chemotherapy alone.
详细描述
Research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal [IP] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy.
This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac® administered immediately post-cytoreductive surgery in women with ovarian cancer. In the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses from the dose-finding phase will be determined. In the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
- •Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel
- •Minimal or non-symptomatic ascites
- •≥18 years old
- •Signed informed consent
排除标准
- •Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
- •Anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy
- •Treatment with a prior investigational agent within 30 days of planned instillation of NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery
- •Known sensitivity to any of the study medication components or the chemotherapy regimen
- •History of prior malignancy other than ovarian that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy
- •Ileostomy or hepatic resection during current cytoreductive surgery
- •Women of childbearing potential not practicing adequate forms of birth control
研究组 & 干预措施
NanoPac® 100 mg/m2
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: NanoPac® 100 mg/m2 (Drug)
NanoPac® 100 mg/m2
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: Standard of Care Intravenous Chemotherapy (Drug)
NanoPac® 200 mg/m2
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: NanoPac® 200 mg/m2 (Drug)
NanoPac® 200 mg/m2
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: Standard of Care Intravenous Chemotherapy (Drug)
NanoPac® 300 mg/m2
Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: NanoPac® 300 mg/m2 (Drug)
NanoPac® 300 mg/m2
Intraperitoneal NanoPac® 300 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: Standard of Care Intravenous Chemotherapy (Drug)
NanoPac® 400 mg/m2
Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: NanoPac® 400 mg/m2 (Drug)
NanoPac® 400 mg/m2
Intraperitoneal NanoPac® 400 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
干预措施: Standard of Care Intravenous Chemotherapy (Drug)
Standard of Care Intravenous Chemotherapy
Standard of care intravenous chemotherapy (with platinum and taxane agents) administered per institutional standards.
干预措施: Standard of Care Intravenous Chemotherapy (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events
时间窗: 12 months
Adverse events will include any clinically relevant changes in laboratory values, vital signs, and physical examination. Treatment-emergent adverse events occur when the date and time of the adverse event onset is on or after the first application of the investigational agent and any time up to when the intravenous chemotherapy commences. Treatment-emergent adverse events will be summarized for each treatment group. The summaries will include an overall summary of the number of subjects reporting and the number of events reported, summaries of adverse events leading to termination or death, and summaries by severity and relatedness (separately and combined). Of greatest interest will be post-surgery signs of toxicity (e.g., severe abdominal pain after 5-7 days, neutropenia, thrombocytopenia, bowel dehiscence, prolonged ileus).
次要结局
- Maximum Plasma Concentration of Paclitaxel (Cmax)(12 months)
- Progression Free Survival (PFS) at 12 Months(12 months post-treatment)