NCT02199171已完成1 期
A Phase I Dose-escalation and Pharmacokinetic Study of Hyperthermic Intraoperative Intraperitoneal Chemotherapy (HIPEC) Carboplatin at the Time of Cytoreductive Surgery for the Initial Treatment in Patients With Advanced Ovarian, Fallopian Tube, and Peritoneal Carcinomas.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of HIPEC carboplatin
研究概览
简要总结
This phase I trial studies the side effects and best dose of heated carboplatin given into the abdomen at the time of surgery in treating patients with stage II-IV ovarian, fallopian tube, or peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating oxaliplatin and infusing it directly into the area around the tumor during surgery may kill more tumor cells.
详细描述
Primary Objectives:
To determine the maximum tolerated dose (MTD) of carboplatin given as HIPEC for primary treatment of women with advanced ovarian, peritoneal, and fallopian tube cancers.
Secondary Objectives:
- To determine the dose limiting toxicities of HIPEC carboplatin.
- To describe the pharmacokinetic profile of HIPEC carboplatin.
- To quantify changes in tissue temperature during HIPEC and compare to conventional temperature measures (esophageal and bladder).
- To describe the extent of thermal damage and DNA platinum adduct formation in tissues resulting from HIPEC carboplatin.
OUTLINE: This is a dose escalation study.
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
- •Patients must have histologically or cytologically confirmed, known or highly suspected advanced (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) ovarian, primary peritoneal, or fallopian tube cancer, scheduled for primary or interval cytoreductive surgery
- •If the patient has received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following: decline in serum carcinoma antigen (CA)125 level, at least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s)
- •Women of all races and ethnic groups are eligible for this trial
- •Gynecologic Oncology Group (GOG) performance status =< 2
- •Leukocytes >= 3,000/microliter (mcL)
- •Absolute neutrophil count >= 1,500/mcL
- •Platelets >= 100,000/mcL
- •Total bilirubin within normal institutional limits
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 2.5 x institutional upper limit of normal
- •Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •Albumin >= 2.5 mg/dL
- •Patients for whom the diagnosis of high-grade serous or undifferentiated carcinoma of ovarian, peritoneal, or fallopian tubal origin is confirmed at surgery
- •Surgery achieves either no gross residual disease or optimal cytoreductive status defined as no single lesion measuring more than 1 cm in its greatest diameter (this protocol calls for the intentional delay in resection of up to 3 tumors per patient until the HIPEC procedure is complete; the surgeon will identify these tumors as easily resectable from a technical and safety aspect)
- •Patients must be stable from cardiopulmonary and hemodynamic standpoints to continue with prolonged surgery and anesthesia
- •Provision of written informed consent
排除标准
- •Patients receiving neo-adjuvant chemotherapy whose disease has progressed following at least 3 cycles, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status), new lesion(s) or increase in maximal diameter of > 20% of the two largest target lesions, rising CA-125 (an increase of at least 10% of baseline value that increases over 3 values obtained every 21 days)
- •Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
- •Patients found to have non-gynecologic, uterine, or breast primary at surgery
- •Patients with gynecologic malignancy of low-grade serous or borderline histology
- •Patients with sub-optimal resection (any single tumor larger than 1 cm)
- •Patients with core body temperature > 37 degrees Celsius (C) at completion of cytoreductive surgery and prior to HIPEC
- •Patients who are receiving other investigational therapeutic agents
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant women are excluded from this study
研究组 & 干预措施
HIPEC carboplatin
Experimental
Patients receive hyperthermic carboplatin intraperitoneally over 60 minutes during the planned surgical cytoreductive procedure.
Doses as appropriate for assigned dose level in 500 cubic centimeters (cc)
干预措施: carboplatin (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of HIPEC carboplatin
时间窗: Up to 30 days after study treatment
MTD of HIPEC carboplatin, defined as the dose level with \< 2 patients of 6 experiencing dose-limiting toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Identified using the continual reassessment method.
次要结局
- Disease control rates, scored according to Response Evaluation Criteria in Solid Tumors criteria and consist of complete response, partial response, and stable disease(Up to 1 year)
- 1-year overall survival (OS) rate(At 1 year)
- Incidence of adverse events assessed using Common Toxicity Criteria version 4.0(Up to 30 days after study treatment)
- Change in pharmacokinetic profile of HIPEC carboplatin(Baseline and at 5, 15, 30, 45, and 60 minutes)
- Changes in tissue temperature during HIPEC compared to conventional temperature measures (esophageal and bladder)(Baseline to after completion of HIPEC)
- Extent of DNA platinum adduct formation in tissues resulting from HIPEC carboplatin(After HIPEC but before the subject leaves the operating room (up to 2 hours))
- Thermal damage in tissues resulting from HIPEC carboplatin(After HIPEC but before the subject leaves the operating room (up to 2 hours))
研究者
Krishnansu
Professor
University of California, Irvine
研究点 (1)
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