Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
This study determine the maximal tolerate dose
详细描述
This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years old
- •Histologically confirmed diagnosis of colorectal or appendix cancer
- •Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery
- •Peritoneal Carcinomatosis Index > 17
- •Previous adjuvant chemotherapy is allowed
- •One or several lines of chemotherapy are allowed
- •Hemoglobin ≥ 10 g/dL (red blood transfusion is allowed if needed), neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3 and white blood cells > 3000 /mm3
- •Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN
- •Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN
- •ECOG (Eastern Cooperative Oncology group) < 1
- •Life expectancy higher than 8 weeks
- •Negative pregnancy test in women of childbearing potential
- •Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment
- •Patients affiliated to a French Social Security System
- •Signed informed consent (IC) obtained before any study specific procedures
排除标准
- •Serum uracile ≥ 16 ng/ml
- •Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)
- •Patients with anesthetic or medical contraindications to surgery
- •Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF
- •Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.
- •Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion
- •History or presence of other cancer within the past 5 years (except adequately treated in situ carcinoma of the cervix and non-melanoma skin cancer)
- •Pregnant or breastfeeding women
- •Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections
- •Participation in another clinical trial within 30 days prior to study entry
- •Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study
- •ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women
研究组 & 干预措施
Oxaliplatin
IP neoadjuvant chemotherapy protocol:
Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.
Intravenous chemotherapy protocol:
Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed.
干预措施: Oxaliplatin (Drug)
Oxaliplatin
IP neoadjuvant chemotherapy protocol:
Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.
Intravenous chemotherapy protocol:
Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed.
干预措施: LV5FU or Folfiri (Drug)
Oxaliplatin
IP neoadjuvant chemotherapy protocol:
Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.
Intravenous chemotherapy protocol:
Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed.
干预措施: Oxycodone (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: through study completion, an average of 3 year
To determine: - Maximum tolerated dose (MTD),
次要结局
- Area Under the Curve (AUC)(through study completion, an average of 3 year)