A Phase II Study of Pancreatic Enzyme Replacement (Zenpep) on Completion Rates of Adjuvant Chemotherapy Among Subjects With Resected Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer
研究概览
简要总结
This research study is evaluating a study drug to treat pancreatic exocrine insufficiency (PEI) during the first year after the diagnosis of pancreatic cancer while the participant is recovering from surgery and receiving adjuvant treatment.
The study drug involved in this study is:
-Zenpep
详细描述
The FDA (the U.S. Food and Drug Administration) has approved Zenpep as a treatment option for PEI. Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.
In this research study, the investigators are studying whether Zenpep will improve the ability of patients to complete adjuvant treatment for their pancreatic cancer after surgery to remove their tumor. The investigators are also studying if Zenpep will have an effect on nutrition status and quality of life for pancreatic cancer patients after they have had surgery to remove their tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Participants must have histologically or cytologically confirmed pancreatic ductal adenocarcinoma. Variants or mixed histology will be included if the predominant histology is adenocarcinoma.
- •Participants must have potentially resectable pancreatic cancer defined as: (1) no detectable metastases (2) signed consent for attempted resection of pancreatic cancer per treating surgeon.
- •ECOG performance status ≤
- •Age >18 years. Participants <18 years old are excluded from this study because subsequent adjuvant therapy is based on therapy guidelines in the adult population.
- •Willingness to consider adjuvant therapy following surgical resection of disease, signed in the consent form attestation.
- •Ability to understand and willingness to provide written informed consent.
- •Pre-operative laboratory values adequate to undergo resection of pancreatic cancer, as defined below:
- •Hemoglobin > 7.0 g/dL;
- •Platelets ≥ 40,000/mL;
- •Creatinine < 2.5 mg/dL or; Creatinine clearance ≥ 20 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
排除标准
- •Pancreatic resection not performed. Intraoperative findings and unforeseen medical exigent circumstances may preclude pancreatic resection. Such outcomes include undetected metastases or vascular involvement, which preclude resection with intent to cure, as well as perioperative medical events including cardiopulmonary complications.
- •Final pathology other than pancreatic ductal adenocarcinoma or primary component other than adenocarcinoma.
- •Any prior chemotherapy and/or radiation for pancreatic cancer at the time of study enrollment, including neoadjuvant chemotherapy and/or radiation therapy.
- •Second malignancy with active disease.
- •History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to pancrelipase
- •Pregnant women are excluded from this study because subsequent adjuvant therapy needed for the primary endpoint is teratogenic. Pancrelipase is category C. Animal reproduction studies have not been conducted on pancrelipase and minimal data is available.
- •Participants unable to self-administer pancrelipase.
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Participants who are receiving any other investigational agents.
- •Participant unable to tolerate oral nutrition.
研究组 & 干预措施
Zenpep
- Pancrelipase (Zenpep) will be administered with every meal (breakfast, lunch, dinner) and snack(s), continuously.
- Participants will begin pancrelipase on the day of enrollment and continue therapy until 1 year after surgery per calendar date
干预措施: Pancrelipase (Drug)
结局指标
主要结局
Effect of Pancreatic Enzyme Replacement Therapy on the Completion Rate of Adjuvant Chemotherapy and Radiation After Surgery for Early Stage Pancreatic Cancer
时间窗: 40 weeks
Completion, or not, of all doses of chemotherapy and fractions of radiation prescribed by the treating oncologist prior to the start of adjuvant treatment
次要结局
- Monitor the Incidence and Severity of Complications After Surgery for Early Stage Pancreatic Cancer(84 days after surgery)
- Measure Grip Strength Before and After Surgery and Adjuvant Treatment for Early-stage Pancreatic Cancer(52 weeks)
- Subject Adherence to Pancreatic Enzyme Replacement Therapy as Determined by Pill Count(52 weeks)
- Subject Adherence to Pancreatic Enzyme Replacement Therapy During Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer(52 weeks)
- Evaluate Quality of Life Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer Using the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Questionnaire(52 weeks)
- Initiation Rate of Adjuvant Treatment for Resected Pancreatic Cancer(84 days after surgery)
- Measure Serum Albumin Levels Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer(52 weeks)
- Measure Body Weight Before and After Surgery and Adjuvant Treatment for Early Stage Pancreatic Cancer(52 weeks)
研究者
A James Moser
Principal Investigator
Dana-Farber Cancer Institute