Octreotide in Treating Patients With Cancer-Related Malignant Ascites
- Conditions
- Metastatic CancerUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: placebo
- Registration Number
- NCT00182754
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I octreotide acetate Patients receive octreotide subcutaneously (SC) once on day 1. Arm II placebo Patients receive placebo SC once on day 1.
- Primary Outcome Measures
Name Time Method Median Time to Paracentesis 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.
- Secondary Outcome Measures
Name Time Method Average Quality-of-life 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';
Number of Paracenteses Up to 2 years We will compare the number of paracenteses between groups. Parametric or nonparametric testing will be used as appropriate.
Trial Locations
- Locations (117)
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
St. Mary - Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸Saint Cloud, Minnesota, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
North Suburban Medical Center
🇺🇸Thornton, Colorado, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Immanuel St. Joseph's
🇺🇸Mankato, Minnesota, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Hematology Oncology Center
🇺🇸Elyria, Ohio, United States
North Coast Cancer Care - Clyde
🇺🇸Clyde, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
St. Anne Mercy Hospital
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States