NCT04361708招募中1 期
A Phase 1 Dose Finding Study of the gFOLFOXIRITAX Regimen Using UGT1A1 Genotype-directed Irinotecan With Fluorouracil, Leucovorin, Oxaliplatin and Taxotere in Patients With Untreated Advanced Upper Gastrointestinal Adenocarcinomas: The I-FLOAT Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The maximum dose tolerated
研究概览
简要总结
The purpose of the proposed study is to establish the safety of combining irinotecan chemotherapy with 5-FU, leucovorin/folinic acid, oxaliplatin, and docetaxel (abbreviated as the I-FLOAT study of gFOLFOXIRITAX) chemotherapies (leucovorin/folinic acid is a vitamin to make 5-FU work well).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastroesophageal adenocarcinoma, cholangiocarcinoma, gallbladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with upper GI primary suspected), or other primary GI malignancy for which the treating physician feels that I-FLOAT is a reasonable therapeutic option.
- •Patients with a history of obstructive jaundice due to the primary tumor must have resolved to <1.5 X upper limit of normal and a metal biliary stent in place
- •Age greater than or equal to 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status =1
- •Life expectancy > 3 months
- •Adequate organ function, as defined by each of the following:
- •Absolute neutrophil count (ANC) = 1500/uL Hemoglobin > 9g/dL (transfusion permitted with stability for > 1 week) Platelets > 100,000/uL Total bilirubin = 1.5 mg/dL AST and ALT = 2.5 X upper limit of normal; alkaline phosphatase = 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis.
- •AST and ALT = 5 X upper limit of normal if hepatic metastases are present. Creatinine = 1.5 mg/dL
- •Measurable or non-measurable disease will be allowed.
- •Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
- •Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
- •Patients taking substrates, inhibitors, or inducers of CYP3A4 should be encouraged to switch to alternative drugs whenever possible, given the potential for drug-drug interactions with irinotecan.
排除标准
- •Prior radiation therapy for any cancer.
- •Prior chemotherapy for metastatic disease Recurrence of disease within 6 months of perioperative chemotherapy are eligible if other eligibility criteria are met
- •Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- •Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v. 4.0*). Pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement.
- •Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.
- •Documented brain metastases
- •Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment.
- •Active uncontrolled bleeding.
- •Pregnancy or breastfeeding.
- •Major surgery within 4 weeks.
- •Previous or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%, and meets all other eligibility criteria.
研究组 & 干预措施
High Risk UGT1A1 genotype
Experimental
干预措施: Oxaliplatin (Drug)
High Risk UGT1A1 genotype
Experimental
干预措施: Docetaxel (Drug)
High Risk UGT1A1 genotype
Experimental
干预措施: Leucovorin (Drug)
High Risk UGT1A1 genotype
Experimental
干预措施: Irinotecan (Drug)
High Risk UGT1A1 genotype
Experimental
干预措施: 5-Fluorouracil (Drug)
Intermediate Risk UGT1A1 genotype
Experimental
干预措施: Oxaliplatin (Drug)
Intermediate Risk UGT1A1 genotype
Experimental
干预措施: Docetaxel (Drug)
Intermediate Risk UGT1A1 genotype
Experimental
干预措施: Leucovorin (Drug)
Intermediate Risk UGT1A1 genotype
Experimental
干预措施: Irinotecan (Drug)
Intermediate Risk UGT1A1 genotype
Experimental
干预措施: 5-Fluorouracil (Drug)
Low Risk UGT1A1 genotype
Experimental
干预措施: Oxaliplatin (Drug)
Low Risk UGT1A1 genotype
Experimental
干预措施: Docetaxel (Drug)
Low Risk UGT1A1 genotype
Experimental
干预措施: Leucovorin (Drug)
Low Risk UGT1A1 genotype
Experimental
干预措施: Irinotecan (Drug)
Low Risk UGT1A1 genotype
Experimental
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
The maximum dose tolerated
时间窗: 1 month
To determine the maximum tolerated dose in the first month of therapy in each of the three main genotype groups (low, intermediate, and high risk) using genotype-guided dosing of irinotecan as part of the I-FLOAT regimen
次要结局
- Cumulative dose of each chemotherapy drug(4 months)
- Total duration of therapy(18 months)
- Overall survival rate(5 years)
- Overall Response Rate(5 years)
- Progression free survival rate(5 years)
研究者
研究点 (1)
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