NCT01294358已完成1 期
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- MTD (Maximum Tolerated Dose)
研究概览
简要总结
Background:
- Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink some of the tumor, but even with chemotherapy only about 25 percent of patients will live for 1 year following diagnosis. Several preliminary studies have shown that it is safe to give chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine over a longer period increases the amount of drug that is available to the tumor. Researchers are interested in studying whether giving the approved pancreatic cancer chemotherapy drug gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of infusion is a safe and effective treatment.
Objectives:
- To test the safety and effectiveness of administering gemcitabine directly to a pancreatic tumor at a slow rate of infusion.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is currently too large to be removed surgically but has not yet spread to other organs.
Design:
- Participants will be screened with a full medical history and physical examination, blood and urine tests, and imaging studies.
- Participants will undergo pancreatic angiography and embolization, during which a catheter will be threaded into the blood vessels near the pancreas and a contrast dye will be used to show the blood vessels supplying the tumor. These blood vessels will then be surgically closed off.
- After the embolization, gemcitabine will be given as an infusion into the area around the tumor over 24 hours.
- Participants will return to the clinical center every 2 weeks after the first infusion for additional infusions of gemcitabine, using the same procedures as above. Participants will be monitored with frequent blood tests and imaging studies.
- Two weeks after the fourth treatment (course 1), participants will have more imaging studies, a physical examination, and blood tests. If the tumor is shrinking, participants will have two more courses of treatment (eight more infusions of gemcitabine).
- Participants will have followup visits every 3 months for 2 years following the last treatment and then every 6 months.
详细描述
Background:
- Pancreatic cancer is the fourth leading cause of cancer death in the United States.
- Surgery offers the only chance at cure; however, less than 20% of patients are considered resectable at initial presentation.
- A common reason for being classified as unresectable is loco-regional advanced disease.
- Several phase I studies of regional administration of chemotherapy have proven safe.
- The main advantage of pancreatic cancer targeted arterial perfusion of Gemcitabine is achievement of higher local bio-available active drug levels at the tumor bed.
- The Regional Chemotherapy in Locally Advanced Pancreatic Cancer (RECLAP) trial is a phase I trial offering highly selective 24-hour intra-arterial administration of Gemcitabine via a subcutaneous port for patients with unresectable locally-advanced pancreatic cancer.
Objectives:
Primary Objective:
- To evaluate feasibility and toxicity of intra-arterial gemcitabine therapy (dose limiting toxicity (DLT)).
- To establish the maximum tolerated dose (MTD)
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine Dose Escalation
Experimental
gemcitabine dose escalation
干预措施: Gemcitabine (Drug)
结局指标
主要结局
MTD (Maximum Tolerated Dose)
时间窗: Cycle 1 (4 weeks), for up to 6 cycles
The MTD is the highest dose that induces dose limiting toxicity (DLT) in no more than 2 patients among a cohort of 6 patients. If 1 or fewer patients experience dose limiting toxicity than the dose level will define the MTD. Only DLT's that occurred during cycle 1 of each dose level were used to determine the MTD.
Number of Participants With Dose Limiting Toxicity (DLT )
时间窗: Cycle 1 (4 weeks), for up to 6 cycles
Here is the number of participants with DLT. DLT is defined as follows: All grade 3 or greater toxicities with the exception of Grade 3 constitutional symptoms that persist for less than 72 hours, Grade 3 and 4 myelosuppression (neutrophils and thrombocytopenia) of less than 5 days duration. Grade 3 metabolic/laboratory events that are correctable within 24 hours. Events that are assessed by the principal investigator as clearly unrelated to the agent will not be considered DLTs (e.g., events directly related to catheter insertion, pain related to underlying disease).
次要结局
- Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.(Every 2 cycles (8 weeks), up to 18 weeks)
- Median Time to Progression(From first day of treatment to the day of progression, assessed up to 221 months)
- Response Rate Using Magnetic Resonance Imaging (MRI)(Every 2 cycles (8 weeks), up to 18 weeks)
- Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)(Every 2 cycles (8 weeks), up to 18 weeks)
- Response Rate Using Positron Emission Tomography (PET)(Every 2 cycles (8 weeks), up to 18 weeks)
- Median Overall Survival (OS)(Overall survival was assessed through study completion, an average of 3 years.)
- Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer(4 months)
- Number of Potential Selection Criteria to Be Used in Future Studies for Patients With Marginally Unresectable Or Unresectable Locally-Advanced Pancreatic Cancer(up to 2.5 years)
- Number of Participants With Serious and Non-Serious Adverse Events(Date treatment consent signed to date off study, approximately 2 years and 2 months and 21 days)
研究者
Udo Rudloff, M.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (1)
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