A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adjuvant Chemotherapy Completion Rate
研究概览
简要总结
The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.
详细描述
OBJECTIVES:
Primary
- To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin.
Secondary
- To determine the morbidity and mortality of this treatment protocol
- To determine time to tumor recurrence and patient survival
- To evaluate the pharmacokinetics of intraoperatively administered cisplatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histopathologic confirmation of malignant pleural mesothelioma
- •Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion or those with minimal disease
- •Male on non-pregnant female
- •18 years of age or older
- •No evidence of spread outside the ipsilateral hemithorax by chest CT and chest MRI
- •Ejection fraction > 45%
- •Pre-operative WBC > 4K/uL
- •Estimated life expectancy of at least 12 weeks
- •Evidence of adequate renal and hepatic function
- •Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan
- •Karnofsky performance status of 70% or greater
- •No evidence of disease progression by chest CT or chest MRI, obtained at 8 weeks following surgery
排除标准
- •Extended disease outside the ipsilateral hemithorax as determined on pre-operative radiographs or intraoperative findings
- •Positive extrapleural nodes as determined by mediastinoscopy
- •Gross disease (estimated thickness > 10mm at any intrathoracic location) present within the hemithorax after surgery
- •Evidence of distant metastatic disease
- •Severe non-malignant co-morbid disease, uncontrolled angina, myocardial infarction on the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
- •Pregnant or breast-feeding
- •Serious concomitant systemic disorders
- •Presence of active concomitant malignancy
- •Psychiatric or addictive disorders, which would preclude informed consent
- •Previous chemotherapy or radiation therapy for mesothelioma
- •Chemotherapy or radiation therapy administered within 3 years for another malignancy
研究组 & 干预措施
Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT
Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
干预措施: Cisplatin (Drug)
Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT
Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
干预措施: Sodium Thiosulfate (Drug)
Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT
Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
干预措施: ALIMTA (Drug)
结局指标
主要结局
Adjuvant Chemotherapy Completion Rate
时间窗: Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.
Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.
次要结局
未报告次要终点
研究者
David J. Sugarbaker, MD
Principal Investigator
Dana-Farber Cancer Institute