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Octreotide in Treating Patients With Cancer-Related Malignant Ascites

2017年2月28日 更新者：Alliance for Clinical Trials in Oncology

An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LARDepot) for Symptomatic Ascites in Cancer Patients

RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites.

PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • Compare the efficacy of octreotide vs placebo, in terms of extending the time-to-paracentesis, in patients with cancer-related symptomatic malignant ascites.

Secondary

  • Compare the number of paracenteses in patients treated with these drugs.
  • Determine the toxicity of octreotide in these patients.
  • Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to anticipated ongoing chemotherapy (yes vs no), frequency of prior paracentesis (never vs other), and prior chemotherapy (never vs only first-line chemotherapy vs second-line chemotherapy vs other). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive octreotide subcutaneously (SC) once on day 1.
  • Arm II: Patients receive placebo SC once on day 1. In both arms, treatment with intramuscular octreotide or placebo repeats monthly for up to 2 years in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, 2 weeks, and then monthly for up to 2 years during study treatment.

After completion of study treatment, patients are followed every 6 months for up to 2 years.

研究类型

介入性

注册 (实际的)

33

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Colorado
      • Aurora、Colorado、美国、80012
        • Aurora Presbyterian Hospital
      • Boulder、Colorado、美国、80301-9019
        • Boulder Community Hospital
      • Colorado Springs、Colorado、美国、80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver、Colorado、美国、80210
        • Porter Adventist Hospital
      • Denver、Colorado、美国、80220
        • Rose Medical Center
      • Denver、Colorado、美国、80218
        • Presbyterian - St. Luke's Medical Center
      • Denver、Colorado、美国、80204
        • St. Anthony Central Hospital
      • Denver、Colorado、美国、80218
        • St. Joseph Hospital
      • Denver、Colorado、美国、80224-2522
        • CCOP - Colorado Cancer Research Program
      • Englewood、Colorado、美国、80110
        • Swedish Medical Center
      • Grand Junction、Colorado、美国、81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Greeley、Colorado、美国、80631
        • North Colorado Medical Center
      • Lone Tree、Colorado、美国、80124
        • Sky Ridge Medical Center
      • Longmont、Colorado、美国、80501
        • Hope Cancer Care Center at Longmont United Hospital
      • Loveland、Colorado、美国、80539
        • McKee Medical Center
      • Pueblo、Colorado、美国、81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton、Colorado、美国、80229
        • North Suburban Medical Center
      • Wheat Ridge、Colorado、美国、80033
        • Exempla Lutheran Medical Center
    • Illinois
      • Joliet、Illinois、美国、60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Moline、Illinois、美国、61265
      • Moline、Illinois、美国、61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Indiana
      • Elkhart、Indiana、美国、46515
        • Elkhart General Hospital
      • Kokomo、Indiana、美国、46904
        • Howard Community Hospital
      • La Porte、Indiana、美国、46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • South Bend、Indiana、美国、46601
        • Memorial Hospital of South Bend
      • South Bend、Indiana、美国、46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend、Indiana、美国、46617
        • Saint Joseph Regional Medical Center
      • South Bend、Indiana、美国、46617
        • South Bend Clinic
    • Iowa
      • Ames、Iowa、美国、50010
        • McFarland Clinic, PC
      • Bettendorf、Iowa、美国、52722
      • Des Moines、Iowa、美国、50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines、Iowa、美国、50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines、Iowa、美国、50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines、Iowa、美国、50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines、Iowa、美国、50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines、Iowa、美国、50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines、Iowa、美国、50307
        • Mercy Capitol Hospital
      • Sioux City、Iowa、美国、51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City、Iowa、美国、51104
        • St. Luke's Regional Medical Center
      • Sioux City、Iowa、美国、51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Chanute、Kansas、美国、66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City、Kansas、美国、67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado、Kansas、美国、67042
        • Cancer Center of Kansas, PA - El Dorado
      • Independence、Kansas、美国、67301
        • Cancer Center of Kansas-Independence
      • Kingman、Kansas、美国、67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence、Kansas、美国、66044
        • Lawrence Memorial Hospital
      • Liberal、Kansas、美国、67901
        • Southwest Medical Center
      • Newton、Kansas、美国、67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons、Kansas、美国、67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt、Kansas、美国、67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina、Kansas、美国、67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington、Kansas、美国、67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita、Kansas、美国、67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita、Kansas、美国、67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita、Kansas、美国、67214
        • CCOP - Wichita
      • Wichita、Kansas、美国、67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita、Kansas、美国、67208
        • Associates in Womens Health, PA - North Review
      • Winfield、Kansas、美国、67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Adrian、Michigan、美国、49221
        • Hickman Cancer Center at Bixby Medical Center
      • Lambertville、Michigan、美国、48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Monroe、Michigan、美国、48162
        • Community Cancer Center of Monroe
      • Monroe、Michigan、美国、48162
        • Mercy Memorial Hospital - Monroe
      • St. Joseph、Michigan、美国、49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Minnesota
      • Alexandria、Minnesota、美国、56308
      • Bemidji、Minnesota、美国、56601
        • MeritCare Bemidji
      • Duluth、Minnesota、美国、55805
        • CCOP - Duluth
      • Duluth、Minnesota、美国、55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth、Minnesota、美国、55805
        • Miller - Dwan Medical Center
      • Fergus Falls、Minnesota、美国、56537
      • Mankato、Minnesota、美国、56002
        • Immanuel St. Joseph's
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic Cancer Center
      • Saint Cloud、Minnesota、美国、56303
        • CentraCare Clinic - River Campus
      • Saint Cloud、Minnesota、美国、56303
        • Coborn Cancer Center
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
      • Billings、Montana、美国、59101
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Billings、Montana、美国、59101
        • Northern Rockies Radiation Oncology Center
      • Billings、Montana、美国、59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings、Montana、美国、59107-7000
        • Billings Clinic - Downtown
      • Butte、Montana、美国、59701
        • St. James Healthcare Cancer Care
      • Great Falls、Montana、美国、59405
        • Great Falls Clinic - Main Facility
      • Great Falls、Montana、美国、59405
      • Havre、Montana、美国、59501
        • Northern Montana Hospital
      • Helena、Montana、美国、59601
        • St. Peter's Hospital
      • Kalispell、Montana、美国、59901
        • Kalispell Regional Medical Center
      • Kalispell、Montana、美国、59901
        • Glacier Oncology, PLLC
      • Kalispell、Montana、美国、59901
        • Kalispell Medical Oncology at KRMC
      • Missoula、Montana、美国、59801
        • Community Medical Center
      • Missoula、Montana、美国、59804
        • Guardian Oncology and Center for Wellness
      • Missoula、Montana、美国、59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula、Montana、美国、59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Omaha、Nebraska、美国、68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha、Nebraska、美国、68122
        • Immanuel Medical Center
      • Omaha、Nebraska、美国、68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha、Nebraska、美国、68131-2197
        • Creighton University Medical Center
    • North Dakota
      • Bismarck、North Dakota、美国、58501
        • Bismarck Cancer Center
      • Bismarck、North Dakota、美国、58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck、North Dakota、美国、58501
        • Mid Dakota Clinic, PC
      • Bismarck、North Dakota、美国、58502
        • St. Alexius Medical Center Cancer Center
      • Fargo、North Dakota、美国、58122
        • CCOP - MeritCare Hospital
      • Fargo、North Dakota、美国、58122
        • MeritCare Broadway
    • Ohio
      • Bowling Green、Ohio、美国、43402
        • Wood County Oncology Center
      • Clyde、Ohio、美国、43410
        • North Coast Cancer Care - Clyde
      • Elyria、Ohio、美国、44035
        • Hematology Oncology Center
      • Lima、Ohio、美国、45804
        • Lima Memorial Hospital
      • Maumee、Ohio、美国、43537
        • St. Luke's Hospital
      • Maumee、Ohio、美国、43537-1839
        • Northwest Ohio Oncology Center
      • Oregon、Ohio、美国、43616
        • St. Charles Mercy Hospital
      • Oregon、Ohio、美国、43616
        • Toledo Clinic - Oregon
      • Sandusky、Ohio、美国、44870
        • North Coast Cancer Care, Incorporated
      • Sylvania、Ohio、美国、43560
        • Flower Hospital Cancer Center
      • Tiffin、Ohio、美国、44883
        • Mercy Hospital of Tiffin
      • Toledo、Ohio、美国、43608
        • St. Vincent Mercy Medical Center
      • Toledo、Ohio、美国、43606
        • Toledo Hospital
      • Toledo、Ohio、美国、43614
        • Medical University of Ohio Cancer Center
      • Toledo、Ohio、美国、43617
        • CCOP - Toledo Community Hospital
      • Toledo、Ohio、美国、43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo、Ohio、美国、43623
        • St. Anne Mercy Hospital
      • Wauseon、Ohio、美国、43567
        • Fulton County Health Center
    • South Dakota
      • Sioux Falls、South Dakota、美国、57105
        • Avera Cancer Institute
      • Sioux Falls、South Dakota、美国、57105
        • Medical X-Ray Center, PC
      • Sioux Falls、South Dakota、美国、57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Virginia
      • Richmond、Virginia、美国、23298-0037
        • Virginia Commonwealth University Massey Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cancer

  • Diagnosis of malignant ascites, as determined by the treating oncologist

    • Positive cytology not required
    • Patient is symptomatic and views ascites as a problem
  • No lymphoma or lymphomatous ascites
  • Planning therapeutic paracentesis ≤ 3 days after study entry OR completed therapeutic paracentesis 2 days before study entry

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 4 weeks

Hematopoietic

  • Not at high risk of bleeding from a procedure

Hepatic

  • No known cirrhosis or portal hypertension

Renal

  • No known history of chronic renal failure, defined as creatinine ≥ 2 times upper limit of normal

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Prior cholecystitis allowed provided patient underwent cholecystectomy
  • No uncontrolled diabetes mellitus
  • No known allergy to octreotide
  • No known allergy to latex
  • No medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent bevacizumab

Chemotherapy

  • No concurrent intraperitoneal chemotherapy

  • No concurrent first-line chemotherapy for any cancer except pancreatic cancer

    • Concurrent second-line chemotherapy or later-line chemotherapy allowed

Endocrine therapy

  • No other concurrent octreotide

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent therapeutic warfarin

    • Concurrent prophylactic warfarin at a dose of 1 mg/day allowed
  • No other concurrent treatment for ascites except paracentesis or ongoing diuretics

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
药品：octreotide acetate
Given subcutaneously
安慰剂比较：Arm II
Patients receive placebo SC once on day 1.
其他：安慰剂
皮下给药

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Median Time to Paracentesis
大体时间：Up to 2 years
Kaplan Meier curves will be constructed for each group; patients lost to follow up will be censored. A log rank test will be used to compare groups. We will adjust for the volume of fluid withdrawn at paracentesis and for change in abdominal circumference between baseline and the next procedure because a patient may require an extra paracentesis if only a small volume is withdrawn at baseline.
Up to 2 years

次要结果测量

结果测量
措施说明
大体时间
Number of Paracenteses
大体时间：Up to 2 years
We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.
Up to 2 years
Average Quality-of-life
大体时间：Up to 2 years
Quality of life will be recorded and analyzed in a descriptive, exploratory fashion. We acknowledge that this study will represent the first to attempt a prospective assessment of quality of life in patients with symptomatic ascites. The underlying hypothesis of this quality of life assessment is that patients who are receiving octreotide will enjoy a better quality of life compared to patients who receive placebo. Quality of life scores from the CLDQ will be summed for all patients on a monthly basis. Again we anticipate high patient drop out rates over time within these two cohorts. With due diligence, we will attempt to ascertain the reason for each patient drop out, and appropriate imputation techniques will be employed for each.Quantified as: 1='All of the time' 2='Most of the time' 3='A good bit of the time' 4='Some of the time' 5='A little bit of the time' 6='Hardly any of the time' 7='None of the time' 0='Missing';
Up to 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年10月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2005年9月15日

首先提交符合 QC 标准的

2005年9月15日

首次发布 (估计)

2005年9月16日

研究记录更新

最后更新发布 (实际的)

2017年4月11日

上次提交的符合 QC 标准的更新

2017年2月28日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NCCTG-N04C2
  • NCI-2009-00647 (注册表标识符：CTRP (Clinical Trials Reporting System))
  • CDR0000440922 (注册表标识符：PDQ (Physician Data Query))

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

安慰剂的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Guinea

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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