Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial

Status: Completed
Location: See all (566) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.

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

• Diagnosis of malignant disease of any stage; (stage I through stage IV)

• No prior history of chemotherapy for any malignancy

• Scheduled to receive intravenous HEC (highly emetogenic chemotherapy) (either cisplatin-containing regimen or doxorubicin and cyclophosphamide \[AC\]); cisplatin, given on a single day, at a dose of \>= 70 mg/m\^2, with or without other chemotherapy agent(s) OR doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2)

• No nausea or vomiting =\< 24 hours prior to registration

• Negative pregnancy test (serum or urine) done =\< 7 days prior to registration, for women of childbearing potential only

• \* 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)

• No known diagnosis of dementia; patients with stable treated brain metastases are eligible to participate

• No known history of central nervous system (CNS) disease (e.g. seizure disorder)

• No treatment with another antipsychotic agent such as olanzapine, risperidone, quetiapine, clozapine, phenothiazine or butyrophenone =\< 30 days prior to registration

• No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy but not within 24 hours prior to registration)

• No use of amifostine within 7 days prior to registration

• No radiotherapy within 7 days prior to registration or planned for one week after the current dose of chemotherapy

• No use of quinolone antibiotic therapy within 7 days prior to registration

• No chronic alcoholism (as determined by the investigator)

• No known hypersensitivity to olanzapine

• No known uncontrolled cardiac arrhythmia, no known uncontrolled congestive heart failure, or no acute myocardial infarction within the previous six months

• No history of uncontrolled diabetes mellitus, i.e., no diabetic ketoacidosis; within 6 months prior to registration; patients are eligible if they have controlled diabetes on diet, oral agents, and/or insulin

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

• Patients must be able to read and comprehend English; local translation, including verbal translation of patient-reported outcomes (PROs) is not permitted

• Serum creatinine =\< 2.0 mg/dL =\< 120 days prior to registration

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) =\< 120 days prior to registration

Locations
United States
Alaska
Fairbanks Memorial Hospital
Fairbanks
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
Mercy Hospital Fort Smith
Fort Smith
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arizona
Kingman Regional Medical Center
Kingman
Mayo Clinic Hospital in Arizona
Phoenix
Mayo Clinic in Arizona
Scottsdale
California
PCR Oncology
Arroyo Grande
Epic Care-Dublin
Dublin
Bay Area Breast Surgeons Inc
Emeryville
Epic Care Partners in Cancer Care
Emeryville
Tibor Rubin VA Medical Center
Long Beach
Contra Costa Regional Medical Center
Martinez
Alta Bates Summit Medical Center - Summit Campus
Oakland
Bay Area Tumor Institute
Oakland
Desert Regional Medical Center
Palm Springs
Epic Care Cyberknife Center
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
The Medical Center of Aurora
Aurora
Boulder Community Foothills Hospital
Boulder
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Rocky Mountain Cancer Centers - Centennial
Centennial
Cancer Center of Colorado at Sloan's Lake
Denver
Colorado Blood Cancer Institute
Denver
Denver Health Medical Center
Denver
National Jewish Health-Main Campus
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
Mountain Blue Cancer Care Center - Swedish
Englewood
Swedish Medical Center
Englewood
National Jewish Health-Western Hematology Oncology
Golden
Grand Valley Oncology
Grand Junction
Saint Mary's Hospital and Regional Medical Center
Grand Junction
North Colorado Medical Center
Greeley
Good Samaritan Medical Center
Lafayette
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Sky Ridge Medical Center
Lone Tree
McKee Medical Center
Loveland
National Jewish Health-Northern Hematology Oncology
Thornton
SCL Health Lutheran Medical Center
Wheat Ridge
Connecticut
Middlesex Hospital
Middletown
Florida
Holy Cross Hospital
Fort Lauderdale
Mayo Clinic in Florida
Jacksonville
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
The Queen's Medical Center - West Oahu
'ewa Beach
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Hawaii Diagnostic Radiology Services LLC
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
Tripler Army Medical Center
Honolulu
University of Hawaii Cancer Center
Honolulu
Straub Medical Center - Kahului Clinic
Kahului
Castle Medical Center
Kailua
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic PC - Ames
Ames
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf
McFarland Clinic PC-Boone
Boone
Saint Anthony Regional Hospital
Carroll
Mercy Hospital
Cedar Rapids
Oncology Associates at Mercy Medical Center
Cedar Rapids
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
JCHC McCreery Cancer Center
Fairfield
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge
Trinity Regional Medical Center
Fort Dodge
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
McFarland Clinic PC-Jefferson
Jefferson
McFarland Clinic PC-Marshalltown
Marshalltown
Ottumwa Regional Health Center
Ottumwa
MercyOne Waterloo Medical Center
Waterloo
Methodist West Hospital
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Kootenai Health - Coeur d'Alene
Coeur D'alene
Walter Knox Memorial Hospital
Emmett
Idaho Urologic Institute-Meridian
Meridian
Saint Alphonsus Medical Center-Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Kootenai Cancer Clinic
Sandpoint
Illinois
Saint Anthony's Health
Alton
Illinois CancerCare-Bloomington
Bloomington
Loyola Center for Health at Burr Ridge
Burr Ridge
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
SIH Cancer Institute
Carterville
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
Carle on Vermilion
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Illinois CancerCare-Dixon
Dixon
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
NorthShore University HealthSystem-Evanston Hospital
Evanston
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Loyola Medicine Homer Glen
Homer Glen
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Loyola University Medical Center
Maywood
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park
Good Samaritan Regional Health Center
Mount Vernon
Cancer Care Center of O'Fallon
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
OSF Saint Anthony Medical Center
Rockford
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
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois CancerCare - Washington
Washington
Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson
Memorial Regional Cancer Center Day Road
Mishawaka
Baptist Health Floyd
New Albany
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
Central Care Cancer Center - Garden City
Garden City
Central Care Cancer Center - Great Bend
Great Bend
Lawrence Memorial Hospital
Lawrence
Kansas Institute of Medicine Cancer and Blood Center
Lenexa
Minimally Invasive Surgery Hospital
Lenexa
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas - Newton
Newton
Menorah Medical Center
Overland Park
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka
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
Kentucky
Baptist Health Corbin
Corbin
Baptist Health Hardin
Elizabethtown
Baptist Health Lexington
Lexington
Baptist Health Louisville
Louisville
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville
Saint Claire Regional Medical Center
Morehead
Owensboro Health Mitchell Memorial Cancer Center
Owensboro
Baptist Health Paducah
Paducah
Louisiana
Louisiana Hematology Oncology Associates
Baton Rouge
Louisiana Hematology Oncology Associates LLC
Baton Rouge
LSU Health Baton Rouge-North Clinic
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
Medical Center of Baton Rouge
Baton Rouge
Ochsner High Grove
Baton Rouge
Our Lady of the Lake Medical Oncology
Baton Rouge
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge
Woman's Hospital
Baton Rouge
Northshore Oncology Associates-Covington
Covington
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington
Oncology Center of The South Incorporated
Houma
Terrebonne General Medical Center
Houma
Ochsner Medical Center Kenner
Kenner
Ochsner LSU Health Monroe Medical Center
Monroe
Ochsner Medical Center Jefferson
New Orleans
LSU Health Sciences Center at Shreveport
Shreveport
Ochsner LSU Health Saint Mary's Medical Center
Shreveport
Massachusetts
Berkshire Medical Center - Cancer Center
Pittsfield
Mercy Medical Center
Springfield
Maryland
Anne Arundel Medical Center
Annapolis
Sinai Hospital of Baltimore
Baltimore
Walter Reed National Military Medical Center
Bethesda
Northwest Hospital Center
Randallstown
UM Saint Joseph Medical Center
Towson
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster
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
Ascension Saint John Hospital
Detroit
Great Lakes Cancer Management Specialists-Doctors Park
East China Township
Green Bay Oncology - Escanaba
Escanaba
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
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
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
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
Spectrum Health Reed City Hospital
Reed City
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills
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
Ascension Saint Joseph Hospital
Tawas City
Munson Medical Center
Traverse City
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
Sanford Joe Lueken Cancer Center
Bemidji
Fairview Ridges Hospital
Burnsville
Minnesota Oncology - Burnsville
Burnsville
Cambridge Medical Center
Cambridge
Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Unity Hospital
Fridley
Mayo Clinic Health Systems-Mankato
Mankato
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
Monticello Cancer Center
Monticello
New Ulm Medical Center
New Ulm
Fairview Northland Medical Center
Princeton
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic in Rochester
Rochester
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Sanford Thief River Falls Medical Center
Thief River Falls
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
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin
Central Care Cancer Center - Bolivar
Bolivar
Parkland Health Center-Bonne Terre
Bonne Terre
Cox Cancer Center Branson
Branson
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Saint Luke's Hospital
Chesterfield
University of Missouri - Ellis Fischel
Columbia
Parkland Health Center - Farmington
Farmington
Centerpoint Medical Center LLC
Independence
Capital Region Southwest Campus
Jefferson City
Freeman Health System
Joplin
Mercy Hospital Joplin
Joplin
Research Medical Center
Kansas City
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Heartland Regional Medical Center
Saint Joseph
Mercy Hospital Saint Louis
Saint Louis
Mercy Hospital South
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mercy Hospital Washington
Washington
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus
Baptist Cancer Center-Grenada
Grenada
Forrest General Hospital / Cancer Center
Hattiesburg
Hattiesburg Clinic - Hematology/Oncology Clinic
Hattiesburg
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
North Carolina
AdventHealth Infusion Center Asheville
Asheville
AdventHealth Infusion Center Haywood
Clyde
Cape Fear Valley Health System
Fayetteville
CaroMont Regional Medical Center
Gastonia
AdventHealth Hendersonville
Hendersonville
CarolinaEast Medical Center
New Bern
CarolinaEast Oncology and Hematology Associates
New Bern
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
Washington
AdventHealth Infusion Center Weaverville
Weaverville
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Sanford South University Medical Center
Fargo
Altru Cancer Center
Grand Forks
Nebraska
Cancer Partners of Nebraska - Pine Lake
Lincoln
Nebraska Hematology and Oncology
Lincoln
Southeast Nebraska Cancer Center - 68th Street Place
Lincoln
Faith Regional Health Services Carson Cancer Center
Norfolk
Great Plains Health Callahan Cancer Center
North Platte
Nebraska Cancer Specialists - Omaha
Omaha
Oncology Hematology West PC
Omaha
Regional West Medical Center Cancer Center
Scottsbluff
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
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 Charleston
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
OptumCare Cancer Care at MountainView
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
James J Peters VA Medical Center
Bronx
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse
Arnot Ogden Medical Center/Falck Cancer Center
Elmira
Glens Falls Hospital
Glens Falls
Northwell Health/Center for Advanced Medicine
Lake Success
NYP/Weill Cornell Medical Center
New York
Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse
Ohio
Aultman Alliance Community Hospital
Alliance
Indu and Raj Soin Medical Center
Beavercreek
Saint Elizabeth Boardman Hospital
Boardman
Aultman Health Foundation
Canton
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Oncology Hematology Care Inc-Kenwood
Cincinnati
Dayton Physician LLC-Miami Valley Hospital North
Dayton
Dayton Veterans Affairs Medical Center
Dayton
Good Samaritan Hospital - Dayton
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
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
First Dayton Cancer Care
Kettering
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
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 Elizabeth Youngstown Hospital
Youngstown
Oklahoma
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Saint Alphonsus Medical Center-Baker City
Baker City
Legacy Mount Hood Medical Center
Gresham
Saint Alphonsus Medical Center-Ontario
Ontario
Legacy Good Samaritan Hospital and Medical Center
Portland
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
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
Phoenixville Hospital
Phoenixville
Pottstown Hospital
Pottstown
Geisinger Cancer Services-Pottsville
Pottsville
Guthrie Medical Group PC-Robert Packer Hospital
Sayre
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 - Spartanburg
Boiling Springs
Ralph H Johnson VA Medical Center
Charleston
Prisma Health Cancer Institute - Laurens
Clinton
Prisma Health Cancer Institute - Easley
Easley
Tidelands Georgetown Memorial Hospital
Georgetown
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
South Dakota
Rapid City Regional Hospital
Rapid City
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Texas
Houston Methodist San Jacinto Hospital
Baytown
Houston Methodist Hospital
Houston
Houston Methodist West Hospital
Houston
Methodist Willowbrook Hospital
Houston
Houston Methodist Saint John Hospital
Nassau Bay
Houston Methodist Sugar Land Hospital
Sugar Land
Houston Methodist The Woodlands Hospital
The Woodlands
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
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Washington
MultiCare Auburn Medical Center
Auburn
Overlake Medical Center
Bellevue
MultiCare Gig Harbor Medical Park
Gig Harbor
Jefferson Healthcare
Port Townsend
MultiCare Good Samaritan Hospital
Puyallup
Valley Medical Center
Renton
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
Mary Bridge Children's Hospital and Health Center
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver
Legacy Salmon Creek Hospital
Vancouver
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Marshfield Clinic-Chippewa Center
Chippewa Falls
Marshfield Medical Center-EC Cancer Center
Eau Claire
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
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
Mayo Clinic Health System-Franciscan Healthcare
La Crosse
Marshfield Clinic - Ladysmith Center
Ladysmith
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
ProHealth D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
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
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Marshfield Clinic-Wausau Center
Wausau
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids
West Virginia
Edwards Comprehensive Cancer Center
Huntington
Saint Mary's Medical Center
Huntington
Wyoming
Cheyenne Regional Medical Center-West
Cheyenne
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Other Locations
Guam
FHP Health Center-Guam
Tamuning
Time Frame
Start Date: 2018-10-15
Completion Date: 2023-05-01
Participants
Target number of participants: 690
Treatments
Experimental: Arm I (fosaprepitant dimeglumine, olanzapine)
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Active_comparator: Arm II (placebo, olanzapine)
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Authors
Demet Gokalp Yasar, Kathleen J. Yost, Deborah W. Wilbur, Kristina Goutsouliak, Mei Dong, Gary V. Burton, Ruby Sharma, Robert J. Behrens, Rinah I. Shopnick, Ralph J. Hauke, Christopher M. George, Joni A. Tilford, Bryan A. Faller, Rakesh Gaur, Sunitha Vemulapalli, Preston D. Steen, Philip A. Lowry, Vijay Chaudhary, Grant R. Seeger, Howard M. Gross, Jay W. Carlson, Jeffrey L. Berenberg, Joseph Sokhn, Jeffrey J. Kirshner, Joseph J. Merchant, Kathryn J. Ruddy, Jorge G. Darcourt, Timothy R. Wassenaar, Charles A. Leath, Donald J. Jurgens, Donald E. Goodin, Jeffrey K. Giguere, John M. Schallenkamp, John A. Ellerton, John J. Inzerillo, Nibal Saad, Elie G. Dib, Wei Song, Keren Sturtz, Arvinder S. Bir, Lauren A. Wiebe, Nisar Ahmad, Shylendra B. Sreenivasappa, Raymond Thertulien, Srilatha B. Hosur, Donald F. Busiek, Puja Nistala, Mohammed T. Masri, Nicholas DiBella, Jonathan D. King, Debra M. Prow, Kimberly W. Schlesinger, Jeremy G. Perkins, Serge Dauphin, Jacqueline Vuky, Qiwei W. Gai, Stephen J. Savage, Shaker R. Dakhil, Sharon D. Luikart, Chandler H. Park, Thomas J. Saphner, Kevin P. Ridenhour, Praveen Vikas, David S. Hanson, Scott M. Lindhorst, Shelly S. Lo, Sarah M. Temkin, Maria T. Grosse-Perdekamp, Kelvin B. Raybon, Rudolph M. Navari, Natalie W. Harper, Richard F. Gorman, David E. Einspahr, Anthony J. Jaslowski, Ravneet Thind, Susanna Hong, Pankaj Gupta, Mukund Nadipuram, Geetika Kumar, James H. Feusner, Barry R. Meisenberg, Scott Brook, Bolanle Gbadamosi, Steven Ades, Prabhjot S. Mundi, Abhishek Tripathi, Srikanth Tamma, Kenneth R. Manning
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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