NCT02178709已完成2 期
A Phase II Study of Neoadjuvant FOLFIRINOX in Patients With Resectable Pancreatic Ductal Adenocarcinoma With Tissue Collection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Pathologic Complete Response
研究概览
简要总结
The primary objective of this study is to evaluate the rate of pathologic complete response to neoadjuvant FOLFIRINOX in patients with resectable pancreatic cancer using a tissue collection component.
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
- •≥ 18 years old at the time of informed consent
- •Able to provide written informed consent and HIPAA authorization
- •ECOG performance status of 0 or 1
- •Patient must be eligible for abdominal surgery
- •Histologically confirmed adenocarcinoma of the pancreas that has been documented to be resectable by standardized radiographic criteria by a pancreatic surgeon
- •Patients must to have tumor tissue collected prior to enrolling on this trial. Up to 10 patients will be accepted with no pre-treatment research tissue collection or tissue collection from an outside institution.
- •a.If the tissue is from an outside institution, it must be reviewed at Indiana University Health Pathology Department if a biopsy was performed outside of this institution.
- •Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX.
- •Any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is classified as WOCBP if she meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •WOCBP and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 8 weeks after the end of treatment.
- •Patients must have adequate organ function as defined by the following laboratory values at study entry:
- •Hemoglobin ≥ 9 g/dL (transfusions are acceptable)
- •ANC ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)
- •Total bilirubin ≤ 1.5 x ULN
- •AST/ALT ≤ 3 x ULN
排除标准
- •Prior therapy for pancreatic adenocarcinoma
- •Other malignancies within the past 3 years except for the following: adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer. Any cancer curatively treated >3 years prior to entry with no clinical evidence of recurrence is permitted.
- •Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).
- •Participation in any investigational drug study within 4 weeks preceding the start of study treatment. Patients are not permitted to participate in another investigational drug study while being treated on this protocol.
- •Inability to receive a port or PICC line.
- •History of or suspected Gilbert's Disease (testing not required if presence is not suspected).
- •Baseline peripheral neuropathy/paresthesia grade ≥
- •Active hepatitis B, unless patient has been on antiviral agents for at least 2 months (baseline testing not required).
- •Active clinically serious infections (> grade 2).
- •Major surgery or significant traumatic injury within 8 weeks of first study drug. A core pancreatic or liver biopsy does not preclude the patient from the study.
- •Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If patients require phenytoin, carbamazepine or phenobarbital monitoring of drug levels is suggested during the study.
- •Pregnant or lactating women.
- •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
研究组 & 干预措施
FOLFIRINOX
Experimental
FOLFIRINOX consists of the following combination of drugs:
- Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle
- Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle
- Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle
- 5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.
- 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle.
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
Percentage of Patients With Pathologic Complete Response
时间窗: Up to 4 months
Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy: I: \<10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: \>90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin
次要结局
- Number of Patients With Treatment-Related Adverse Events Grade 3 or Above(Every 15 days for approximately 6 months)
- Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX(Up to 4 months)
- Rate of R0 Resection(Up to 4 months)
- Disease Free Survival(Up to 3 years)
- Disease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)(Up to 4 months)
- Overall Survival(Up to 4 years)
- Objective Response Rate (Percentage of Patients With Complete Response or Partial Response)(Up to 4 months)
研究者
Anita Turk
Assistant Professor of Clinical Medicine
Indiana University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
eoadjuvant FOLFIRINOX for borderline or locally advanced pancreatic cancerJPRN-jRCT1051190099Toyama Hirochika25
Unknown
2 期
Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic CancerBorderline Resectable Pancreatic CancerNCT02717091Nagoya University50
已完成
2 期
Neoadjuvant Modified FOLFIRINOX in Borderline Resectable Pancreatic CancerPancreatic AdenocarcinomaNCT02749136Asan Medical Center44
已完成
不适用
Phase II study of neoadjuvant FOLFIRINOX or nab-paclitaxel with gemcitabine for borderline resectable pancreatic cancerPancreatic cancerJPRN-UMIN000017718Department of Surgical Oncology, Nagoya University Graduate School of Medicine50
招募中
不适用
A trial of Neoadjuvant modified FOLFIRINOX chemotherapy for resectable pancreatic adenocarcinomaNeoplasmsKCT0004421Yonsei University Health System, Severance Hospital27