A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy
研究概览
简要总结
Background:
Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow.
Objective:
To find a better way to treat advanced stomach cancer.
Eligibility:
People ages 18 and older with stomach cancer that has spread throughout their belly.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Scans
Cancer sample: If they do not have one, they will have a biopsy.
Tests of performance of normal activities
Dietary assessment
Participants will have a laparoscopy. Small cuts are made into their abdomen. A thin camera with a light is inserted. Small instruments are used to take biopsies. This will be repeated during the study to monitor the cancer. During the first laparoscopy, a port with a catheter attached will be put into the abdomen.
Participants may also have an endoscopy: A thin tube with a camera is inserted through the mouth and into the stomach. The tube collects samples to monitor the cancer.
Participants will get paclitaxel every 3 weeks through the abdominal port and through a small plastic tube in an arm vein. They will also take capecitabine by mouth twice daily for the first 15 days of a 21-day cycle.
After participants finish 3 cycles, they will have scans to see how they are doing. They may get another course of therapy.
Participants will have visits every 3 weeks during treatment. Then they will have follow-up visits for 5 years. Then they will keep in touch with researchers for the rest of their life.
详细描述
Background:
- An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.)
- Peritoneal metastasis is a common finding at diagnosis, making curative surgical resection possible in an estimated 25% of patients.
- Systemic chemotherapy is the recommended treatment for patients with metastatic gastric cancer to the peritoneal cavity, however selective use of cytoreductive surgery and intraperitoneal chemotherapy has been associated with improved overall survival.
- Multiple chemotherapeutic agents and delivery systems have been described for intraperitoneal therapy, but no standard regimen exists.
Objective:
-Determine the intraperitoneal progression free survival (iPFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy.
Eligibility:
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: Paclitaxel (Drug)
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: Capecitabine (Drug)
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: Paclitaxel (Drug)
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: Capecitabine (Drug)
Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: Paclitaxel (Drug)
Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: Capecitabine (Drug)
Paclitaxel Intraperitoneal 20mg & Intravenous 80mg Every 3Weeks & Capecitabine 825mg/m^2 Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: BardPort Titanium Implanted Port with Peritoneal Catheter (Device)
Paclitaxel Intraperitoneal 60mg & Intravenous 80mg Every 3Weeks &Capecitabine 825mg/m^2 Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: BardPort Titanium Implanted Port with Peritoneal Catheter (Device)
Paclitaxel Intraperitoneal & Intravenous Every 3 Weeks & Capecitabine Twice Daily
Intraperitoneal (IP) and intravenous (IV) paclitaxel administration with concomitant oral capecitabine
干预措施: BardPort Titanium Implanted Port with Peritoneal Catheter (Device)
结局指标
主要结局
Progression Free Survival (PFS) in Participants With Peritoneal Metastases From Gastric Cancer After Repeated Intraperitoneal Chemotherapeutic Infusion (IPC) and Systemic Paclitaxel Administration With Concomitant Capecitabine Therapy
时间窗: From the first treatment to progression of disease, up to 2 years and 1 month
PFS is the amount of time a participant survives without progression of disease after treatment with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined as an increase in peritoneal cancer index (PCI) score of greater than 4 points from baseline PCI, new ascites requiring repeat (more than 1) therapeutic paracentesis, malignant bowel obstruction, new intraperitoneal nodules or masses concerning for peritoneal metastasis, and decline in performance status not attributable to other medical causes.
次要结局
- Intra-peritoneal Progression Free Survival (iPFS) Reported With an 80% Confidence Interval(From the first treatment to progression of disease, up to 2 years and 1 month)
- Overall Survival (OS)(From first treatment until death, an average of 1.5 years)
- Number of Grades 3-5 Serious and/or Non-serious Adverse Events Related to the Research Interventions(Date treatment consent signed to date off study, 18 months and 8 days; and 25 months and 10 days for the first and second group, respectively.)
- Intra-peritoneal Progression Free Survival (iPFS) Reported With an 95% Confidence Interval(From the first treatment to progression of disease, up to 2 years and 1 month)
- Frequency of Objective Histopathologic Response to Therapy(At end of each course (3 treatment cycles; 9 weeks))
- Number of Participants With Distant Extra-peritoneal Disease-free Survival(From start of treatment to until time of extra-peritoneal progression, an average of 1 year)
- Number of Participants With Intra-peritoneal Progression Free Survival (iPFS)(At extra-peritoneal progression, an average of 1 year)
研究者
Andrew Blakely
Principal Investigator
National Institutes of Health Clinical Center (CC)