Octreotide in Treating Patients With Cancer-Related Malignant Ascites
28 de febrero de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
33
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Estados Unidos, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Estados Unidos, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Estados Unidos, 80210
- Porter Adventist Hospital
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Denver, Colorado, Estados Unidos, 80220
- Rose Medical Center
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Estados Unidos, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Estados Unidos, 80218
- St. Joseph Hospital
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Denver, Colorado, Estados Unidos, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Estados Unidos, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Estados Unidos, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Estados Unidos, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Estados Unidos, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Estados Unidos, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Estados Unidos, 80539
- McKee Medical Center
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Pueblo, Colorado, Estados Unidos, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Estados Unidos, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Estados Unidos, 80033
- Exempla Lutheran Medical Center
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Illinois
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Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Moline, Illinois, Estados Unidos, 61265
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Moline, Illinois, Estados Unidos, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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Elkhart, Indiana, Estados Unidos, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Estados Unidos, 46904
- Howard Community Hospital
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La Porte, Indiana, Estados Unidos, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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South Bend, Indiana, Estados Unidos, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Estados Unidos, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Estados Unidos, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Estados Unidos, 46617
- South Bend Clinic
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Estados Unidos, 52722
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Des Moines, Iowa, Estados Unidos, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Estados Unidos, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Estados Unidos, 50307
- Mercy Capitol Hospital
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Estados Unidos, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Estados Unidos, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - El Dorado
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Independence, Kansas, Estados Unidos, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Estados Unidos, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Estados Unidos, 67901
- Southwest Medical Center
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Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Estados Unidos, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- CCOP - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Estados Unidos, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Estados Unidos, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, Estados Unidos, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, Estados Unidos, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Estados Unidos, 48162
- Mercy Memorial Hospital - Monroe
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St. Joseph, Michigan, Estados Unidos, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Minnesota
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Alexandria, Minnesota, Estados Unidos, 56308
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Bemidji, Minnesota, Estados Unidos, 56601
- MeritCare Bemidji
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Duluth, Minnesota, Estados Unidos, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Estados Unidos, 55805
- Miller - Dwan Medical Center
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Fergus Falls, Minnesota, Estados Unidos, 56537
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Mankato, Minnesota, Estados Unidos, 56002
- Immanuel St. Joseph's
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Estados Unidos, 56303
- Coborn Cancer Center
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Montana
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Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Estados Unidos, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Estados Unidos, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Estados Unidos, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Estados Unidos, 59107-7000
- Billings Clinic - Downtown
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Butte, Montana, Estados Unidos, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Estados Unidos, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Estados Unidos, 59405
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Havre, Montana, Estados Unidos, 59501
- Northern Montana Hospital
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Helena, Montana, Estados Unidos, 59601
- St. Peter's Hospital
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Kalispell, Montana, Estados Unidos, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Estados Unidos, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Estados Unidos, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Estados Unidos, 59801
- Community Medical Center
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Missoula, Montana, Estados Unidos, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Estados Unidos, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Estados Unidos, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Estados Unidos, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Estados Unidos, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Estados Unidos, 68131-2197
- Creighton University Medical Center
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Estados Unidos, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Broadway
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Ohio
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Bowling Green, Ohio, Estados Unidos, 43402
- Wood County Oncology Center
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Clyde, Ohio, Estados Unidos, 43410
- North Coast Cancer Care - Clyde
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Elyria, Ohio, Estados Unidos, 44035
- Hematology Oncology Center
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Lima, Ohio, Estados Unidos, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Estados Unidos, 43537
- St. Luke's Hospital
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Maumee, Ohio, Estados Unidos, 43537-1839
- Northwest Ohio Oncology Center
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Oregon, Ohio, Estados Unidos, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Estados Unidos, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Estados Unidos, 44870
- North Coast Cancer Care, Incorporated
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Sylvania, Ohio, Estados Unidos, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Estados Unidos, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
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Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Estados Unidos, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Estados Unidos, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Estados Unidos, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Estados Unidos, 43567
- Fulton County Health Center
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Richmond, Virginia, Estados Unidos, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm I
Patients receive octreotide subcutaneously (SC) once on day 1.
|
Given subcutaneously
|
|
Comparador de placebos: Arm II
Patients receive placebo SC once on day 1.
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Administrado por vía subcutánea
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Median Time to Paracentesis
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Paracenteses
Periodo de tiempo: 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
|
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Average Quality-of-life
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2005
Finalización primaria (Actual)
1 de septiembre de 2009
Finalización del estudio (Actual)
1 de marzo de 2013
Fechas de registro del estudio
Enviado por primera vez
15 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
15 de septiembre de 2005
Publicado por primera vez (Estimar)
16 de septiembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
28 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCCTG-N04C2
- NCI-2009-00647 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000440922 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .