A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer

Who is this study for? Patients with Non-small Cell Lung Carcinoma
What treatments are being studied? Naloxegol
Status: Terminated
Location: See all (660) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Advanced (stage IIIB or IV) non-small cell lung cancer diagnosed by biopsy of the primary or metastatic site (American Joint Committee on Cancer 7.0)

• No known presence of known EGFR or EML4-ALK driver mutations in the tumor

• Started first-line systemic therapy of the investigator's choice within 12 weeks prior to registration, or planning to initiate first-line systemic therapy of the investigator's choice within 4 weeks after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiation

• No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy (other than current treatment); prior palliative radiation permitted; prior adjuvant systemic therapy /radiation is permitted

• No more than 7 days of prior use of mixed opioid agonist/opioid antagonists or other opioid antagonists within 4 weeks before registration; patients should not receive such medications after registration and for the entire duration of study treatment

• No methadone within 4 weeks prior to registration

• Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration; current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required

• Expected survival \> 3 months

• No concurrently active second invasive malignancies except non-melanoma skin cancer

• No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall; no abdominal surgery within 60 days of registration

• No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)

• No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer's disease, or uncontrolled seizures)

‣ No symptomatic and untreated brain metastases; patients will be eligible for study if radiation therapy for brain metastases was completed at least 7 days prior to registration

⁃ Patients having received stereotactic radiation will be eligible if the radiation was completed at least 7 days prior to registration

⁃ Patients having undergone surgical resection of brain metastases will be eligible after they have healed and recovered from the surgical intervention sufficiently to start systemic treatment for NSCLC, as determined by a neurosurgeon

⁃ No known leptomeningeal carcinomatosis

• No history of myocardial infarction =\< 6 months prior to registration; no current symptomatic congestive heart failure, uncontrolled angina, or uncontrolled cardiac arrhythmias

• No severe hepatic impairment (Child-Pugh class C) or acute liver disease

• No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients

• No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers

• Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Absolute neutrophil count (ANC) \>= 1,500/mm\^3

• Platelet count \>= 100,000/mm\^3

• Calculated (calc.) creatinine clearance \>= 60 mL/min calculated using the Cockcroft-Gault formula

• Total bilirubin =\< 1.2 x upper limit of normal (ULN) unless due to Gilbert's disease

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Fairbanks Memorial Hospital
Fairbanks
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arizona
Kingman Regional Medical Center
Kingman
California
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
PCR Oncology
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Tibor Rubin VA Medical Center
Long Beach
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
USC Norris Oncology/Hematology-Newport Beach
Newport Beach
Keck Medical Center of USC Pasadena
Pasadena
Mission Hope Medical Oncology - Santa Maria
Santa Maria
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
The Medical Center of Aurora
Aurora
University of Colorado Hospital
Aurora
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Memorial Hospital North
Colorado Springs
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
UCHealth Memorial Hospital Central
Colorado Springs
Cancer Center of Colorado at Sloan's Lake
Denver
Colorado Blood Cancer Institute
Denver
Denver Health Medical Center
Denver
Kaiser Permanente-Franklin
Denver
National Jewish Health-Main Campus
Denver
Porter Adventist Hospital
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Rose Medical Center
Denver
SCL Health Saint Joseph Hospital
Denver
The Women's Imaging Center
Denver
Western Surgical Care
Denver
Mercy Medical Center
Durango
Southwest Oncology PC
Durango
Mountain Blue Cancer Care Center - Swedish
Englewood
Swedish Medical Center
Englewood
Mountain Blue Cancer Care Center
Golden
National Jewish Health-Western Hematology Oncology
Golden
Saint Mary's Hospital and Regional Medical Center
Grand Junction
North Colorado Medical Center
Greeley
Good Samaritan Medical Center
Lafayette
Kaiser Permanente-Rock Creek
Lafayette
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Rocky Mountain Cancer Centers-Littleton
Littleton
Kaiser Permanente-Lone Tree
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Sky Ridge Medical Center
Lone Tree
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
McKee Medical Center
Loveland
Parker Adventist Hospital
Parker
Rocky Mountain Cancer Centers-Parker
Parker
Rocky Mountain Cancer Centers - Pueblo
Pueblo
Saint Mary Corwin Medical Center
Pueblo
National Jewish Health-Northern Hematology Oncology
Thornton
Rocky Mountain Cancer Centers-Thornton
Thornton
SCL Health Lutheran Medical Center
Wheat Ridge
Connecticut
Middlesex Hospital
Middletown
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
Nanticoke Memorial Hospital
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Florida
Broward Health Medical Center
Fort Lauderdale
Holy Cross Hospital
Fort Lauderdale
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Memorial Hospital West
Pembroke Pines
South Florida Baptist Hospital
Plant City
Saint Anthony's Hospital Cancer Care Center
Saint Petersburg
Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Low Country Cancer Care Associates PC
Savannah
Summit Cancer Care-Candler
Savannah
Hawaii
Hawaii Cancer Care - Savio
'aiea
Pali Momi Medical Center
'aiea
Queen's Cancer Center - Pearlridge
'aiea
The Cancer Center of Hawaii-Pali Momi
'aiea
Hawaii Cancer Care Inc-Liliha
Honolulu
Hawaii Cancer Care Inc-POB II
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic PC - Ames
Ames
McFarland Clinic PC-Boone
Boone
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Alegent Health Mercy Hospital
Council Bluffs
Greater Regional Medical Center
Creston
Broadlawns Medical Center
Des Moines
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Des Moines
Medical Oncology and Hematology Associates-Laurel
Des Moines
Mercy Medical Center - Des Moines
Des Moines
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge
Trinity Regional Medical Center
Fort Dodge
McFarland Clinic PC-Jefferson
Jefferson
McFarland Clinic PC-Marshalltown
Marshalltown
Siouxland Regional Cancer Center
Sioux City
Mercy Medical Center-West Lakes
West Des Moines
Methodist West Hospital
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Mountain States Tumor Institute
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Kootenai Medical Center
Coeur D'alene
Walter Knox Memorial Hospital
Emmett
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland
Idaho Urologic Institute-Meridian
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian
Saint Alphonsus Medical Center-Nampa
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa
Kootenai Cancer Center
Post Falls
Kootenai Cancer Clinic
Sandpoint
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls
Illinois
Rush - Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
SIH Cancer Institute
Carterville
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
University of Illinois
Chicago
Carle on Vermilion
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Illinois CancerCare-Dixon
Dixon
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Joliet Oncology-Hematology Associates Limited
Joliet
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Cancer Care Center of O'Fallon
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Illinois CancerCare-Pekin
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
West Suburban Medical Center
River Forest
Memorial Medical Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Rush-Copley Healthcare Center
Yorkville
Indiana
Memorial Regional Cancer Center Day Road
Mishawaka
Reid Health
Richmond
Memorial Hospital of South Bend
South Bend
Kansas
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
HaysMed University of Kansas Health System
Hays
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas-Manhattan
Manhattan
Cancer Center of Kansas - McPherson
Mcpherson
Cancer Center of Kansas - Newton
Newton
Olathe Health Cancer Center
Olathe
University of Kansas Cancer Center-Overland Park
Overland Park
Cancer Center of Kansas - Parsons
Parsons
Ascension Via Christi - Pittsburg
Pittsburg
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Salina Regional Health Center
Salina
University of Kansas Health System Saint Francis Campus
Topeka
Cancer Center of Kansas - Wellington
Wellington
University of Kansas Hospital-Westwood Cancer Center
Westwood
Ascension Via Christi Hospitals Wichita
Wichita
Associates In Womens Health
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Cancer Center of Kansas - Winfield
Winfield
Kentucky
Flaget Memorial Hospital
Bardstown
Commonwealth Cancer Center-Corbin
Corbin
Hardin Memorial Hospital
Elizabethtown
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
Saint Joseph London
London
Jewish Hospital
Louisville
Jewish Hospital Medical Center Northeast
Louisville
Saints Mary and Elizabeth Hospital
Louisville
Saint Claire Regional Medical Center
Morehead
Jewish Hospital Medical Center South
Shepherdsville
Massachusetts
Beverly Hospital
Beverly
Addison Gilbert Hospital
Gloucester
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth
Mercy Medical Center
Springfield
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
Bronson Battle Creek
Battle Creek
IHA Hematology Oncology Consultants-Brighton
Brighton
Saint Joseph Mercy Brighton
Brighton
IHA Hematology Oncology Consultants-Canton
Canton
Saint Joseph Mercy Canton
Canton
Caro Cancer Center
Caro
IHA Hematology Oncology Consultants-Chelsea
Chelsea
Saint Joseph Mercy Chelsea
Chelsea
Hematology Oncology Consultants-Clarkston
Clarkston
Newland Medical Associates-Clarkston
Clarkston
Beaumont Hospital - Dearborn
Dearborn
Ascension Saint John Hospital
Detroit
Great Lakes Cancer Management Specialists-Doctors Park
East China Township
Michigan State University Clinical Center
East Lansing
Green Bay Oncology - Escanaba
Escanaba
Beaumont Hospital - Farmington Hills
Farmington Hills
Genesee Cancer and Blood Disease Treatment Center
Flint
Genesee Hematology Oncology PC
Flint
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
William Beaumont Hospital-Grosse Point
Grosse Pointe
Academic Hematology Oncology Specialists
Grosse Pointe Woods
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods
Allegiance Health
Jackson
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
McLaren-Greater Lansing
Lansing
Sparrow Hospital
Lansing
Hope Cancer Clinic
Livonia
Saint Mary Mercy Hospital
Livonia
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb
Michigan Breast Specialists-Macomb Township
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette
Mercy Health Mercy Campus
Muskegon
Lakeland Hospital Niles
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores
21st Century Oncology-Pontiac
Pontiac
Hope Cancer Center
Pontiac
Newland Medical Associates-Pontiac
Pontiac
Saint Joseph Mercy Oakland
Pontiac
Huron Medical Center PC
Port Huron
Lake Huron Medical Center
Port Huron
Spectrum Health Reed City Hospital
Reed City
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills
Michigan Cancer Specialists
Roseville
Cancer Care Associates PC
Royal Oak
Comprehensive Medical Center PLLC
Royal Oak
Hematology Oncology Consultants PC
Royal Oak
Oakland Colon and Rectal Association
Royal Oak
Oakland Medical Group
Royal Oak
William Beaumont Hospital-Royal Oak
Royal Oak
Ascension Saint Mary's Hospital
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Lakeland Medical Center Saint Joseph
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights
Mitchell Folbe MD PC
Sterling Heights
Premier Hematology Oncology Care
Sterling Heights
Ascension Saint Joseph Hospital
Tawas City
Munson Medical Center
Traverse City
Claudia BR Herke MD PC
Troy
Hematology Oncology Consultants PC-Troy
Troy
Michigan Institute of Urology-Town Center
Troy
William Beaumont Hospital - Troy
Troy
Advanced Breast Care Center PLLC
Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren
Macomb Hematology Oncology PC
Warren
Michigan Breast Specialists-Warren
Warren
Saint John Macomb-Oakland Hospital
Warren
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
Metro Health Hospital
Wyoming
Huron Gastroenterology PC
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti
Minnesota
Riverwood Healthcare Center
Aitkin
Sanford Joe Lueken Cancer Center
Bemidji
Essentia Health Saint Joseph's Medical Center
Brainerd
Fairview Ridges Hospital
Burnsville
Cambridge Medical Center
Cambridge
Mercy Hospital
Coon Rapids
Essentia Health - Deer River Clinic
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes
Essentia Health Cancer Center
Duluth
Essentia Health Saint Mary's Medical Center
Duluth
Miller-Dwan Hospital
Duluth
Fairview Southdale Hospital
Edina
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls
Essentia Health - Fosston
Fosston
Unity Hospital
Fridley
Essentia Health Hibbing Clinic
Hibbing
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
Minneapolis VA Medical Center
Minneapolis
University of Minnesota/Masonic Cancer Center
Minneapolis
Monticello Cancer Center
Monticello
New Ulm Medical Center
New Ulm
Essentia Health - Park Rapids
Park Rapids
Fairview Northland Medical Center
Princeton
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic in Rochester
Rochester
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Essentia Health Sandstone
Sandstone
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Sanford Thief River Falls Medical Center
Thief River Falls
Essentia Health Virginia Clinic
Virginia
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Sanford Cancer Center Worthington
Worthington
Fairview Lakes Medical Center
Wyoming
Missouri
Parkland Health Center-Bonne Terre
Bonne Terre
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Parkland Health Center - Farmington
Farmington
Capital Region Southwest Campus
Jefferson City
Kansas City Veterans Affairs Medical Center
Kansas City
Truman Medical Centers
Kansas City
University of Kansas Cancer Center - North
Kansas City
University of Kansas Cancer Center - Lee's Summit
Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City
Missouri Baptist Medical Center
Saint Louis
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus
Baptist Cancer Center-Grenada
Grenada
University of Mississippi Medical Center
Jackson
Baptist Memorial Hospital and Cancer Center-Union County
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Saint Vincent Frontier Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
Southeastern Medical Oncology Center-Clinton
Clinton
Duke University Medical Center
Durham
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Wayne Memorial Hospital
Goldsboro
Maria Parham Hospital
Henderson
Margaret R Pardee Memorial Hospital
Hendersonville
Onslow Memorial Hospital
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
Vidant Oncology-Kenansville
Kenansville
Vidant Oncology-Kinston
Kinston
Scotland Memorial Hospital-Laurinburg Cancer Center
Laurinburg
Southeastern Regional Medical Center
Lumberton
Vidant Oncology-Richlands
Richlands
WG Hefner VA Medical Center
Salisbury
Johnston Memorial Hospital
Smithfield
North Dakota
Sanford Bismarck Medical Center
Bismarck
Essentia Health Cancer Center-South University Clinic
Fargo
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Sanford South University Medical Center
Fargo
Essentia Health - Jamestown Clinic
Jamestown
Nebraska
CHI Health Saint Francis
Grand Island
CHI Health Good Samaritan
Kearney
Heartland Hematology and Oncology
Kearney
Saint Elizabeth Regional Medical Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Hematology and Oncology Consultants PC
Omaha
Nebraska Methodist Hospital
Omaha
Midlands Community Hospital
Papillion
New Hampshire
New Hampshire Oncology Hematology PA-Concord
Concord
New Hampshire Oncology Hematology PA-Hooksett
Hooksett
The Dana-Farber Cancer Institute at Londonderry
Londonderry
Nevada
Carson Tahoe Regional Medical Center
Carson City
21st Century Oncology-Henderson
Henderson
Cancer and Blood Specialists-Henderson
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson
Las Vegas Cancer Center-Henderson
Henderson
Las Vegas Urology - Green Valley
Henderson
Las Vegas Urology - Pebble
Henderson
OptumCare Cancer Care at Seven Hills
Henderson
Urology Specialists of Nevada - Green Valley
Henderson
21st Century Oncology
Las Vegas
21st Century Oncology-Fort Apache
Las Vegas
21st Century Oncology-Vegas Tenaya
Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Ann M Wierman MD LTD
Las Vegas
Cancer and Blood Specialists-Shadow
Las Vegas
Cancer and Blood Specialists-Tenaya
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
Desert West Surgery
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas
Hope Cancer Care of Nevada
Las Vegas
Las Vegas Cancer Center-Medical Center
Las Vegas
Las Vegas Prostate Cancer Center
Las Vegas
Las Vegas Urology - Cathedral Rock
Las Vegas
Las Vegas Urology - Pecos
Las Vegas
Las Vegas Urology - Smoke Ranch
Las Vegas
Las Vegas Urology - Sunset
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
OptumCare Cancer Care at MountainView
Las Vegas
OptumCare Cancer Care at Oakey
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
Sunrise Hospital and Medical Center
Las Vegas
University Cancer Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
Urology Specialists of Nevada - Central
Las Vegas
Urology Specialists of Nevada - Northwest
Las Vegas
Urology Specialists of Nevada - Southwest
Las Vegas
Hope Cancer Care of Nevada-Pahrump
Pahrump
Radiation Oncology Associates
Reno
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Hematology Oncology Associates of Central New York-Auburn
Auburn
Northwell Health Imbert Cancer Center
Bay Shore
Roswell Park Cancer Institute
Buffalo
Veterans Affairs Western New York Health Care System-Buffalo
Buffalo
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse
Arnot Ogden Medical Center/Falck Cancer Center
Elmira
Northwell Health/Center for Advanced Medicine
Lake Success
Rochester General Hospital
Rochester
University of Rochester
Rochester
Stony Brook University Medical Center
Stony Brook
Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse
Ohio
Indu and Raj Soin Medical Center
Beavercreek
Strecker Cancer Center-Belpre
Belpre
Saint Elizabeth Boardman Hospital
Boardman
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Adena Regional Medical Center
Chillicothe
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
Oncology Hematology Care Inc-Kenwood
Cincinnati
TriHealth Cancer Institute-Anderson
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel East Hospital
Columbus
Mount Carmel Health Center West
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Dayton Physician LLC-Miami Valley Hospital North
Dayton
Good Samaritan Hospital - Dayton
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Delaware Radiation Oncology
Delaware
Grady Memorial Hospital
Delaware
Dublin Methodist Hospital
Dublin
Armes Family Cancer Center
Findlay
Blanchard Valley Hospital
Findlay
Orion Cancer Care
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Dayton Physicians LLC-Atrium
Franklin
Dayton Physicians LLC-Wayne
Greenville
Wayne Hospital
Greenville
Mount Carmel Grove City Hospital
Grove City
First Dayton Cancer Care
Kettering
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
OhioHealth Marion General Hospital
Marion
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Southern Ohio Medical Center
Portsmouth
Springfield Regional Cancer Center
Springfield
Springfield Regional Medical Center
Springfield
Dayton Physicians LLC-Upper Valley
Troy
Upper Valley Medical Center
Troy
Saint Joseph Warren Hospital
Warren
Saint Ann's Hospital
Westerville
Saint Elizabeth Youngstown Hospital
Youngstown
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Alphonsus Medical Center-Baker City
Baker City
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
Coos Bay
Providence Newberg Medical Center
Newberg
Saint Alphonsus Medical Center-Ontario
Ontario
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Saint Charles Health System-Redmond
Redmond
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem
Christiana Care Health System-Concord Health Center
Chadds Ford
Geisinger Medical Center
Danville
Pocono Medical Center
East Stroudsburg
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Lehigh Valley Hospital-Hazleton
Hazleton
Geisinger Medical Oncology-Lewisburg
Lewisburg
Lewistown Hospital
Lewistown
Geisinger Cancer Services-Pottsville
Pottsville
Community Medical Center
Scranton
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Geisinger Medical Group
State College
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
South Carolina
Prisma Health Cancer Institute - Laurens
Clinton
Prisma Health Cancer Institute - Easley
Easley
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Self Regional Healthcare
Greenwood
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
Prisma Health Cancer Institute - Spartanburg
Spartanburg
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Memorial Hospital
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Memorial GYN Plus
Ooltewah
Texas
Saint Joseph Regional Cancer Center
Bryan
Dallas VA Medical Center
Dallas
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork
Sandra L Maxwell Cancer Center
Cedar City
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center
Provo
Riverton Hospital
Riverton
Dixie Medical Center Regional Cancer Center
Saint George
LDS Hospital
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
Augusta Health Center for Cancer and Blood Disorders
Fishersville
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
MultiCare Auburn Medical Center
Auburn
Overlake Hospital Medical Center
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Harrison Medical Center
Bremerton
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Saint Elizabeth Hospital
Enumclaw
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
MultiCare Gig Harbor Medical Park
Gig Harbor
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Jefferson Healthcare
Port Townsend
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
MultiCare Good Samaritan Hospital
Puyallup
Valley Medical Center
Renton
Kaiser Permanente Washington
Seattle
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Providence Regional Cancer System-Shelton
Shelton
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley
Franciscan Research Center-Northwest Medical Plaza
Tacoma
Mary Bridge Children's Hospital and Health Center
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
Duluth Clinic Ashland
Ashland
Northwest Wisconsin Cancer Center
Ashland
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Marshfield Medical Center-EC Cancer Center
Eau Claire
Aurora Health Center-Fond du Lac
Fond Du Lac
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
Holy Family Memorial Hospital
Manitowoc
Aurora Bay Area Medical Group-Marinette
Marinette
Saint Vincent Hospital Cancer Center at Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
Cancer Center of Western Wisconsin
New Richmond
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
HSHS Saint Nicholas Hospital
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Marshfield Clinic Stevens Point Center
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Marshfield Clinic-Wausau Center
Wausau
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Clinic - Weston Center
Weston
Wyoming
Cheyenne Regional Medical Center-West
Cheyenne
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Time Frame
Start Date: 2018-03-23
Completion Date: 2023-04-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Group I (lower dose naloxegol, placebo)
Patients receive lower dose naloxegol PO QD and placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Active_comparator: Group II (placebo, higher dose naloxegol)
Patients receive placebo PO QD and higher dose naloxegol PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Placebo_comparator: Group III (placebo)
Patients receive placebo PO QD. Courses repeat every 3 weeks in year 1 and then every 3 months in year 2 in the absence of unacceptable toxicity.
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov