KCT0005802尚未招募未知
Phase I,II Study of first line Intraperitoneal Paclitaxel with Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients with Advanced Gastric Cancer with Peritoneal Metastasis
The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 61 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) age 20 to 80 years
- •2) ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
- •3) Pathologically proven primary gastric adenocarcinoma
- •4) Peritoneal metastasis confirmed by laparoscopy or diagnostic imaging
- •5) Written informed consent
- •6) Adequate function of important organs (within 14 days before registration)
- •Absolute neutrophil count =1.5 x 10^9/L
- •Platelet >=100,000/mm3
- •Hemoglobin >=8.0g/dL
- •T-Bilirubin <= = 2.0mg/dl or ULN x 1.5
- •AST <=100U/L
- •ALT <=100U/L
- •Creatinine clearance = 50mL/min
排除标准
- •1) Other active concomitant malignancies
- •2) HER2 positive (Immunohistochemostry 3+ or 2+ with in situ hybridization positive)
- •3) No investigational anticancer therapy within 30 days prior to the first dose of study treatment
- •4) recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease
- •5) uncontrolled acute or chronic disease
- •6) uncontrolled infection or inflammation
- •7) uncontrolled psychiatric disorder or central neurologic disease
- •8) not fully recovered from previous surgery
- •9) prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months
- •10) intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome
- •11) Fertile males and females who are unwilling to use effective contraceptive methods.
- •12) Pregnancy, breast feeding or intention to become pregnant
- •13) interstitial pneumonia or pulmonary fibrosis
- •14) Peripheral neuropathy with functional impairment
- •15) Hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL.
- •16) concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4
- •17) Concomitant therapy with sorivudine or brivudine
- •18) Dihydropyrimidine dehydrogenase (DPD) deficiency.
- •19) Current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium
研究者
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