A Pilot Study of Intravenous Ascorbic Acid and Folfirinox in the Treatment of Advanced Pancreatic Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
研究概览
简要总结
This pilot clinical trial studies the side effects of ascorbic acid and combination chemotherapy in treating patients with pancreatic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Nutrients found in food and dietary supplements, such as ascorbic acid, may improve the tolerability of chemotherapy regimens. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may work better in treating patients with pancreatic cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine safety of intravenous ascorbic acid in combination with fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin (FOLFIRINOX) as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 in patients with advanced pancreatic cancer.
SECONDARY OBJECTIVES:
I. To test feasibility of collecting quality of life (QOL), patient reported outcomes (PRO) data and correlative studies on patients with advanced 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving informed consent
- •Histological diagnosis of adenocarcinoma of the pancreas
- •Stage IV or recurrent pancreatic cancer by imaging
- •Locally advanced unresectable pancreatic cancer by National Comprehensive Cancer Network (NCCN) criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- •No prior treatment for metastatic disease (prior neo-adjuvant or adjuvant chemotherapy, except FOLFIRINOX, chemoradiation or radiation allowed)
- •White blood count >= 3000
- •Platelets >= 100,000
- •Total bilirubin =< 1.5 mg/dl
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 X upper limit of normal (ULN)
- •Creatinine < 1.5 mg/dL
- •Glucose-6-phosphatase deficiency (G6PD) level of 5-14 units/g hemoglobin (Hgb) or within institutional standard parameters
- •All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study
排除标准
- •Other pancreatic cancer histology (islet cell, acinar, neuroendocrine tumors)
- •Resectable pancreatic cancer
- •Prior neoadjuvant FOLFIRINOX
- •Pregnant or lactating females
- •No clinical ascites (mild ascites on scans permissible)
- •Central nervous system (CNS) metastasis
- •Known congestive heart failure, significant ventricular arrhythmias, cirrhosis, grade 4/5 chronic kidney disease, uncontrolled diabetes
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •Peripheral neuropathy grade 2 or greater
- •Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.)
研究组 & 干预措施
Treatment (FOLFIRINOX, ascorbic acid)
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Oxaliplatin (Drug)
Treatment (FOLFIRINOX, ascorbic acid)
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Irinotecan Hydrochloride (Drug)
Treatment (FOLFIRINOX, ascorbic acid)
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Leucovorin Calcium (Drug)
Treatment (FOLFIRINOX, ascorbic acid)
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Fluorouracil (Drug)
Treatment (FOLFIRINOX, ascorbic acid)
Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1. Patients then receive ascorbic acid IV over 2 hours on days 3, 5, 8, 10 and 12. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: Ascorbic Acid (Dietary Supplement)
结局指标
主要结局
Number of Participants With Adverse Events as Determined by CTCAE Version 4.03
时间窗: Up to 28 days after the last treatment
After 4 patients are enrolled on the study and receive at least one dose of intravenous ascorbic acid, the data will be reviewed. If 2 out of the 4 cannot complete 2 courses of FOLFIRINOX then the study will be halted.
次要结局
- Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30(Baseline to up to 28 days after the last treatment)