Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- R0 Resection Rate - Borderline Resectable Prostate Cancer Participants
研究概览
简要总结
The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.
详细描述
Primary Objective:
- The primary objective of this study is to evaluate the efficacy of sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in improving R0 resection rate in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
Secondary Objectives:
- Evaluate the safety and tolerability of sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
- Evaluate progression-free survival (PFS) in patients treated with sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines.
- Evaluate overall survival (OS) in patients treated with sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
- Evaluate the objective response rate (ORR) in patients treated with sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
- Evaluate the disease control rate (DCR) in patients treated with Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
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 must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
- •Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus.
- •Age 18 or above.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patients must have organ and marrow function as defined below:
- •Hemoglobin ≥8 g/dL
- •Absolute neutrophil count ≥1,500/mcL
- •Platelets ≥100,000/mcL
- •Total bilirubin ≤1.5 X institutional upper limit of normal
- •AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- •Creatinine ≤1.5 X institutional upper limit of normal or CrCL>50
- •It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
- •If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg/dL, then this inclusion criteria is met.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
排除标准
- •Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer.
- •Patients receiving any other investigational anti-neoplastic agents.
- •History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible.
- •Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed.
- •Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient's safety.
- •Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible.
- •Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment.
- •Patients who are pregnant or breastfeeding.
研究组 & 干预措施
Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)
-
Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.
-
nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month.
-
1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR
-
1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off
-
mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1; Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1; 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion; Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1.
-
1 Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle
干预措施: Radiological Assessments (Other)
Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)
-
Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.
-
nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month.
-
1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR
-
1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off
-
mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1; Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1; 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion; Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1.
-
1 Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle
干预措施: mFOLFIRINOX (Drug)
Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)
-
Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.
-
nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month.
-
1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR
-
1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off
-
mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1; Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1; 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion; Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1.
-
1 Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle
干预措施: Nab paclitaxel (Drug)
Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)
-
Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.
-
nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month.
-
1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR
-
1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off
-
mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1; Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1; 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion; Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1.
-
1 Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle
干预措施: Gemcitabine (Drug)
结局指标
主要结局
R0 Resection Rate - Borderline Resectable Prostate Cancer Participants
时间窗: Approximately every 8 weeks, up to 9 months
The R0 resection is assessed only in patients who undergo surgery. R0 resection is a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. Participants are considered to be evaluable if they receive at least one sequence of treatments with GA and mFFX (1 cycle GA followed by 1 cycle of m FFX). Primary analysis for each cohort will calculate the R0 resection rate with one-sided 95% confidence interval.
R0 Resection Rate - Locally Advanced Prostate Cancer Participants
时间窗: Approximately every 8 weeks, up to 9 months
The R0 resection is assessed only in patients who undergo surgery. R0 resection is a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. Participants are considered to be evaluable if they receive at least one sequence of treatments with GA and mFFX (1 cycle GA followed by 1 cycle of m FFX). Primary analysis for each cohort will calculate the R0 resection rate with one-sided 95% confidence interval.
次要结局
- Progression-Free Survival (PFS)(Up to 1 year after completion of study intervention)
- Overall Survival (OS)(Up to 1 year after completion of study intervention)
- Incidences of Adverse Events - Safety(Up to 1 year after completion of study intervention)
- Number of Participants to Complete Study Intervention- Tolerability(9 months)
- Disease Control(Up to 1 year after completion of study intervention)
- Tumor Response(Up to 1 year after completion of study intervention)