Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- MTD of gemcitabine hydrochloride defined as the dose at which no more than 3 of 6 patients experience grade 3 or greater adverse events, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
研究概览
简要总结
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. To determine the maximum tolerate dose (MTD) of intra-tumoral injection of gemcitabine (gemcitabine hydrochloride) when administered as a one time initial induction therapy in conjunction (=< 33 hours) prior to conventional multimodality treatment for locally advanced pancreatic cancer (LAPC).
SECONDARY OBJECTIVES:
I. To evaluate the initial and delayed toxicity associated with this treatment regimen.
OUTLINE: This is a dose-escalation study.
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
- •Histologically or cytology proven pancreatic ductal carcinoma
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0,1 or 2
- •Absolute neutrophil count (ANC) >= 1500
- •Platelets (PLT) >= 100,000
- •Hemoglobin (HgB) > 9.0 g/dL
- •Total bilirubin < 2.0 x upper limit of normal (ULN)
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 5 x ULN
- •Creatinine =< 1.5 mg/dL
- •Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
- •Provide informed written consent
- •Imaging, a combination of at least two of the following (computed tomography [CT], magnetic resonance imaging [MRI], endoscopic ultrasound [EUS]) staging the pancreatic mass as "locally advanced"
- •EUS clinically indicated for staging, and/or celiac neurolysis
- •Resection declined by surgical staff based on designation of LAPC
- •Willing to provide blood samples
- •Willing to receive their standard multimodality therapy at Mayo Clinic, Rochester
- •Willing to return to Mayo Clinic, Rochester during the observation phase
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •Any prior treatment (chemotherapy, radiation) for pancreatic cancer
- •Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- •History of myocardial infarction =< 168 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •Prior pancreatic surgery
- •Pancreatic tumor histology other than carcinoma (e.g. islet cell, lymphoma, etc.)
研究组 & 干预措施
Treatment (gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride IT on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil IV on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
干预措施: gemcitabine hydrochloride (Drug)
Treatment (gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride IT on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil IV on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
干预措施: fluorouracil (Drug)
Treatment (gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride IT on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil IV on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
干预措施: radiation therapy (Radiation)
Treatment (gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride IT on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil IV on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
MTD of gemcitabine hydrochloride defined as the dose at which no more than 3 of 6 patients experience grade 3 or greater adverse events, as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
时间窗: 4 weeks
次要结局
- Incidence of delayed adverse events associated with this treatment, graded according to the NCI CTCAE v3.0(4 weeks after completing standard systemic chemotherapy)
- Incidence of immediate adverse events associated with this treatment, graded according to the NCI CTCAE version (v)3.0(Within 72 hours of EUS)