BrUOG 295:Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of Adjuvant FOLFOX-A
研究概览
简要总结
The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a better regimen in the adjuvant setting for patients with resected pancreatic cancer. This protocol will obtain preliminary data on safety and disease-free and overall survival following administration of FOLFOX-A for patients with resected pancreatic cancer.
详细描述
See summary above
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
- •Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer, managed with a potentially curative resection (i.e., removal of all gross tumor). Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
- •Interval between definitive tumor-related surgery and registration between 21-70 days.
- •Patients will be staged according to the 6th edition AJCC staging system with pathologic stage T1-3, N0-1, M-0 being eligible.
- •Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.
- •Preexisting neuropathy < grade 1 (per CTCAE).
- •ECOG performance status 0 or
- •Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause of lack of menses >12 months) do not need to have a pregnancy test, please document status.
- •Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
- •Required Initial Laboratory Values:
- •Neutrophils ≥ 1,500/mm3
- •Platelet count ≥ 100,000/mm3
- •Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
- •Total bilirubin ≤ 1.5 x ULN
- •AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN
- •Alkaline phosphatases < 2.5x ULN
- •Abdominal CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 6 weeks of registration on study. Patients can have PET/MRI of the chest/abdomen instead.
排除标准
- •Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
- •Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion would put the patient at risk if re-exposed
- •Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.
- •Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a different cancer is allowable. Patients must not have received chemotherapy for a year prior to registering on study
- •No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible. This must be documented.
研究组 & 干预措施
FOLFOXA
Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
干预措施: FOLFOXA (Drug)
结局指标
主要结局
Feasibility of Adjuvant FOLFOX-A
时间窗: Up to 24 weeks
Determination of the feasibility of administration of adjuvant FOLFOX-A in patients who have undergone resection of pancreatic cancer.Successful administration of FOLFOX-A will be defined as the ability to receive ≥8 cycles of FOLFOX-A.
次要结局
- Disease-free Survival(Through study completion, an average of 3 years.)