Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

Last updated: January 14, 2025
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Gastroenteritis

Stomach Discomfort

Colic

Treatment

Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)

Olanzapine

Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)

Clinical Study ID

NCT02116530
A221301
NCI-2014-00446
U10CA031946
  • Ages > 18
  • All Genders

Study Summary

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

Eligibility Criteria

Inclusion

  • Diagnosis of malignant disease

  • No prior chemotherapy and scheduled to receive HEC (either cisplatin-containing regimen or anthracycline + cyclophosphamide [AC])

  • Cisplatin at a dose of ≥70mg/m^2, with or without other chemotherapy agent(s) OR

  • Anthracycline (60 mg/m^2) plus cyclophosphamide(600 mg/m^2)

  • Age ≥18 years

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

  • Required Initial Laboratory Values ≤ 120 days prior to registration

  • Serum Creatinine ≤2.0 mg/dL

  • Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic oxaloacetic transaminase (SGPT) ≤3 x Upper Limit of Normal (ULN)

  • Absolute neutrophil count (ANC) ≥1500/mm^3

  • 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 (per clinician discretion)

  • No severe cognitive compromise

  • No known history of CNS disease (e.g. brain metastases, seizure disorder)

  • No treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to registration or planned during protocol therapy

  • No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy)

  • No concurrent use of amifostine

  • No concurrent abdominal radiotherapy

  • No concurrent use of quinolone antibiotic therapy

  • No chronic alcoholism (as determined by the investigator)

  • No known hypersensitivity to olanzapine

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

  • No history of uncontrolled diabetes mellitus (e.g. on insulin or an oral hypoglycemic agent)

Study Design

Total Participants: 401
Treatment Group(s): 4
Primary Treatment: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Phase: 3
Study Start date:
August 20, 2014
Estimated Completion Date:
June 15, 2017

Study Description

Patients with cancer may receive chemotherapy that may cause nausea and vomiting. The purpose of this study is to determine if the use of olanzapine in combination with antiemetic therapy can significantly reduce nausea and vomiting in a large number of patients receiving chemotherapy. Patients are randomized to one of two treatment arms. Please see the "Arms and Intervention" sections for more detailed information. The primary objective is to compare the number of patients with no nausea for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) and overall periods (0-120 hours post-chemotherapy) for patients receiving HEC. The secondary objectives are:

  1. To compare the complete response (CR) (no emetic episodes and no use of rescue medication) in the acute, delayed and overall periods

  2. To compare the incidences of potential toxicities ascribed to olanzapine

Protocol treatment is to begin ≤ 14 days of registration. Patients will receive treatment on Days 1-4. Patients will be permitted to take rescue therapy of the treating investigator's choice for nausea and/or emesis/retching, based on clinical circumstances. After completing treatment, patients will be monitored for side effects.

Connect with a study center

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Alaska Regional Hospital

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Alaska Women's Cancer Care

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska 98508
    United States

    Site Not Available

  • Anchorage Oncology Centre

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska 99504
    United States

    Site Not Available

  • Katmai Oncology Group

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Providence Alaska Medical Center

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California 91505
    United States

    Site Not Available

  • Epic Care-Dublin

    Dublin, California 94568
    United States

    Site Not Available

  • Bay Area Breast Surgeons Inc

    Emeryville, California 94608
    United States

    Site Not Available

  • Epic Care Partners in Cancer Care

    Emeryville, California 94608
    United States

    Site Not Available

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Contra Costa Regional Medical Center

    Martinez, California 945553
    United States

    Site Not Available

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California 94609
    United States

    Site Not Available

  • Bay Area Tumor Institute

    Oakland, California 94609
    United States

    Site Not Available

  • Hematology and Oncology Associates-Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • Saint Mary Corwin Medical Center

    Pueblo, California 81004
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado 80012
    United States

    Site Not Available

  • The Medical Center of Aurora

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Boulder Community Hospital

    Boulder, Colorado 80301
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado 80304
    United States

    Site Not Available

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado 80901
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80907
    United States

    Site Not Available

  • Exempla Saint Joseph Hospital

    Denver, Colorado 80218
    United States

    Site Not Available

  • Porter Adventist Hospital

    Denver, Colorado 80210
    United States

    Site Not Available

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado 80220
    United States

    Site Not Available

  • Rose Medical Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • Mercy Medical Center

    Durango, Colorado 81301
    United States

    Site Not Available

  • Southwest Oncology PC

    Durango, Colorado 81301
    United States

    Site Not Available

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Swedish Medical Center

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Mountain Blue Cancer Care Center

    Golden, Colorado 80401
    United States

    Site Not Available

  • North Colorado Medical Center

    Greeley, Colorado 80631
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Saint Anthony Hospital

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Littleton Adventist Hospital

    Littleton, Colorado 80122
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Sky Ridge Medical Center

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Longmont United Hospital

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado 80501
    United States

    Site Not Available

  • McKee Medical Center

    Loveland, Colorado 80539
    United States

    Site Not Available

  • Parker Adventist Hospital

    Parker, Colorado 80138
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Parker

    Parker, Colorado 80138
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers - Pueblo

    Pueblo, Colorado 81008
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado 80260
    United States

    Site Not Available

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Saint Francis Hospital and Medical Center

    Hartford, Connecticut 06105
    United States

    Site Not Available

  • Beebe Medical Center

    Lewes, Delaware 19958
    United States

    Site Not Available

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Christiana Gynecologic Oncology LLC

    Newark, Delaware 19713
    United States

    Site Not Available

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware 19713
    United States

    Site Not Available

  • Helen F Graham Cancer Center

    Newark, Delaware 19713
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware 19713
    United States

    Site Not Available

  • Regional Hematology and Oncology PA

    Newark, Delaware 19713
    United States

    Site Not Available

  • Beebe Health Campus

    Rehoboth Beach, Delaware 19971
    United States

    Site Not Available

  • Nanticoke Memorial Hospital

    Sanford, Delaware 19973
    United States

    Site Not Available

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware 19801
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Florida Hospital Memorial Medical Center

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Phoebe Putney Memorial Hospital

    Albany, Georgia 31701
    United States

    Site Not Available

  • Oncare Hawaii Inc-Pali Momi

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Pali Momi Medical Center

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • The Cancer Center of Hawaii-Leeward

    'Ewa Beach, Hawaii 96706
    United States

    Site Not Available

  • Oncare Hawaii Inc-Pali Momi

    Aiea, Hawaii 96701
    United States

    Site Not Available

  • The Cancer Center of Hawaii-Leeward

    Ewa Beach, Hawaii 96706
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Kuakini Medical Center

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • OnCare Hawaii-Liliha

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Oncare Hawaii Inc-Kuakini

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Straub Clinic and Hospital

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Tripler Army Medical Center

    Honolulu, Hawaii 96859
    United States

    Site Not Available

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii 96766
    United States

    Site Not Available

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho 83706
    United States

    Site Not Available

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho 83712
    United States

    Site Not Available

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho 83619
    United States

    Site Not Available

  • Saint Luke's Mountain States Tumor Institute - Meridian

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Saint Luke's Mountain States Tumor Institute - Nampa

    Nampa, Idaho 83686
    United States

    Site Not Available

  • Saint Luke's Mountain States Tumor Institute-Twin Falls

    Twin Falls, Idaho 83301
    United States

    Site Not Available

  • Saint Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Memorial Hospital of Carbondale

    Carbondale, Illinois 62902
    United States

    Site Not Available

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Advocate Sherman Hospital

    Elgin, Illinois 60123
    United States

    Site Not Available

  • Illinois CancerCare Galesburg

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Ingalls Memorial Hospital

    Harvey, Illinois 60426
    United States

    Site Not Available

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois 62864
    United States

    Site Not Available

  • Oconomowoc Memorial Hospital-ProHealth Care Inc

    Oconomowoc, Illinois 53066
    United States

    Site Not Available

  • Illinois CancerCare-Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61603
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Valley Radiation Oncology

    Peru, Illinois 61354
    United States

    Site Not Available

  • OSF Saint Anthony Medical Center

    Rockford, Illinois 61108
    United States

    Site Not Available

  • Memorial Medical Center

    Springfield, Illinois 62781
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Waukesha Memorial Hospital

    Waukesha, Illinois 53188
    United States

    Site Not Available

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana 46544
    United States

    Site Not Available

  • Memorial Hospital of South Bend

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Mary Greeley Medical Center

    Ames, Iowa 50010
    United States

    Site Not Available

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa 50010
    United States

    Site Not Available

  • McFarland Clinic PC-Boone

    Boone, Iowa 50036
    United States

    Site Not Available

  • Mercy Hospital

    Cedar Rapids, Iowa
    United States

    Site Not Available

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa 52402
    United States

    Site Not Available

  • Iowa Lutheran Hospital

    Des Moines, Iowa 50316
    United States

    Site Not Available

  • Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Mercy Medical Center-Sioux City

    Des Moines, Iowa 51102
    United States

    Site Not Available

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa 50501
    United States

    Site Not Available

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa 50129
    United States

    Site Not Available

  • McFarland Clinic PC-Marshalltown

    Marshalltown, Iowa 50158
    United States

    Site Not Available

  • Mercy Medical Center - North Iowa

    Mason City, Iowa 50401
    United States

    Site Not Available

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Regional Cancer Center

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Methodist West Hospital

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Baptist Health Corbin

    Corbin, Kentucky 40701
    United States

    Site Not Available

  • Hardin Memorial Hospital

    Elizabethtown, Kentucky 42701
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Newton-Wellesley Hospital

    Newton, Massachusetts 02462
    United States

    Site Not Available

  • Botsford Hospital

    Farmington, Michigan 48336
    United States

    Site Not Available

  • William Beaumont Hospital - Troy

    Troy, Michigan 48098
    United States

    Site Not Available

  • Mercy Hospital-Joplin

    Joplin, Missouri 64804
    United States

    Site Not Available

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri 65401
    United States

    Site Not Available

  • Phelps County Regional Medical Center

    Rolla, Missouri 65401
    United States

    Site Not Available

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Saint Louis Cancer and Breast Institute-South City

    Saint Louis, Missouri 63109
    United States

    Site Not Available

  • CoxHealth South Hospital

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Mercy Hospital Springfield

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina 28328
    United States

    Site Not Available

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina 27534
    United States

    Site Not Available

  • Wayne Memorial Hospital

    Goldsboro, North Carolina 27534
    United States

    Site Not Available

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Southeastern Medical Oncology Center-Wilson

    Wilson, North Carolina 27893
    United States

    Site Not Available

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio 45420
    United States

    Site Not Available

  • Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Central Vermont Medical Center

    Berlin, Vermont 05602
    United States

    Site Not Available

  • Central Vermont Medical Center

    Berlin Corners, Vermont 05602
    United States

    Site Not Available

  • University of Vermont College of Medicine

    Burlington, Vermont 05405
    United States

    Site Not Available

  • Providence Regional Cancer System-Yelm

    Yelm, Washington 98597
    United States

    Site Not Available

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wisconsin 82001
    United States

    Site Not Available

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin 54729
    United States

    Site Not Available

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin 54701
    United States

    Site Not Available

  • Saint Agnes Hospital/Agnesian Cancer Center

    Fond Du Lac, Wisconsin 54935
    United States

    Site Not Available

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin 54303
    United States

    Site Not Available

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • Saint Mary's Hospital

    Green Bay, Wisconsin 54303
    United States

    Site Not Available

  • Saint Vincent Hospital

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin 54221
    United States

    Site Not Available

  • Bay Area Medical Center

    Marinette, Wisconsin 54143
    United States

    Site Not Available

  • Marshfield Clinic

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin 54548
    United States

    Site Not Available

  • D N Greenwald Center

    Mukwonago, Wisconsin 53149
    United States

    Site Not Available

  • Westfields Hospital/Cancer Center of Western Wisconsin

    New Richmond, Wisconsin 54017
    United States

    Site Not Available

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin 54154
    United States

    Site Not Available

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin 54501
    United States

    Site Not Available

  • Lakeview Medical Center-Marshfield Clinic

    Rice Lake, Wisconsin 54868
    United States

    Site Not Available

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin 54868
    United States

    Site Not Available

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Wisconsin 48073
    United States

    Site Not Available

  • Saint Nicholas Hospital

    Sheboygan, Wisconsin 53081
    United States

    Site Not Available

  • Marshfield Clinic Cancer Care at Saint Michael's Hospital

    Stevens Point, Wisconsin 54481
    United States

    Site Not Available

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin 54235
    United States

    Site Not Available

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin 54401
    United States

    Site Not Available

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin 54476
    United States

    Site Not Available

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin 54494
    United States

    Site Not Available

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