Feasibility, Efficacy and Safety of Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) With Oxaliplatin, Cisplatin and Doxorubicin in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancers and Primary Tumors of the Peritoneum: An Open-label, Two-arms, Phase I-II Clinical Trial. PI-CaP
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.
研究概览
简要总结
Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin, or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors.
- •Patients aged between 18 and 78 years.
- •Performance status sec. ECOG ≤ 2
- •Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers.
- •Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC.
- •Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range.
- •Written informed consent.
- •Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria.
排除标准
- •Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis.
- •Bowel obstruction.
- •Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
- •Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
- •Creatinine clearance < 60 ml /min.
- •Pregnancy.
- •Previous treatment reaching the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones.
- •Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin.
- •Patients of both sexes who do not conduct complete abstinence from heterosexual relationships or agree to use an effective clinically acceptable method (with failure rate <1%) during the study and the following 6 months after the last treatment.
研究组 & 干预措施
cohort A
Cohort A: For patients that have indication for systemic therapy with standard chemotherapy. This cohort has a phase II design; the Objective Response Rate (ORR) will be evaluated according to the RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC with Cisplatin (7.5 mg/m²) + Doxorubicin (1.5 mg/m2 ) or Oxaliplatin (92 mg/m2) according to the primary cancer, in association with standard systemic chemotherapy.
干预措施: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose (Drug)
cohort B
Cohort B: For patients that have not indication for systemic therapy with standard chemotherapy. This cohort has a phase I design; with a dose-escalation design the maximum tolerated doses and recommended doses of Cisplatin + Doxorubicin and Oxaliplatin (according to the pathology) administered through PIPAC in patients with peritoneal carcinomatosis will be evaluated.
干预措施: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose (Drug)
结局指标
主要结局
Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.
时间窗: 18 weeks
次要结局
- The overall survival (OS)(30 months)
- The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC(30 months)
- The degree of histological regression assessed by pathological review(18 weeks)
- Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0).(22 weeks)
- The Peritoneal Carcinomatosis Index (PCI) before and after therapy(18 weeks)