Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
- Conditions
- Hematopoietic/Lymphoid CancerNausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT02116530
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Chemotherapy + Antiemetic treatment Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * placebo Placebo + Chemotherapy + Antiemetic treatment Placebo Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * placebo Olanzapine + Chemotherapy + Antiemetic treatment Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy) Placebo + Chemotherapy + Antiemetic treatment Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * placebo Olanzapine + Chemotherapy + Antiemetic treatment Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy) Olanzapine + Chemotherapy + Antiemetic treatment Olanzapine Patients will receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs: * Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus * Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus * Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus * olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
- Primary Outcome Measures
Name Time Method Proportion of Patients With no Nausea 0 to 120 hours after chemotherapy No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.
- Secondary Outcome Measures
Name Time Method Median Nausea Scores Baseline and Day 2 to Day 6 after chemotherapy Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Proportion of Patients With Complete Response 0 to 120 hours after chemotherapy Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire Baseline and day 2 to 6 days after chemotherapy Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Frequency of Rescue Medication Day 2 to Day 6 after chemotherapy Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.
Trial Locations
- Locations (177)
Southwest Oncology PC
🇺🇸Durango, Colorado, United States
Saint Luke's Mountain States Tumor Institute - Nampa
🇺🇸Nampa, Idaho, United States
Illinois CancerCare Galesburg
🇺🇸Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
🇺🇸Galesburg, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Phelps County Regional Medical Center
🇺🇸Rolla, Missouri, United States
Southeastern Medical Oncology Center-Jacksonville
🇺🇸Jacksonville, North Carolina, United States
Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Green Bay Oncology - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Katmai Oncology Group
🇺🇸Anchorage, Alaska, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Anchorage Associates in Radiation Medicine
🇺🇸Anchorage, Alaska, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
Rocky Mountain Cancer Centers-Boulder
🇺🇸Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
🇺🇸Longmont, Colorado, United States
McFarland Clinic PC-William R Bliss Cancer Center
🇺🇸Ames, Iowa, United States
Mercy Hospital
🇺🇸Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
OSF Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Rocky Mountain Cancer Centers-Aurora
🇺🇸Aurora, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
🇺🇸Denver, Colorado, United States
Exempla Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
🇺🇸Denver, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
Froedtert and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Alaska Regional Hospital
🇺🇸Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
🇺🇸Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
🇺🇸Anchorage, Alaska, United States
Anchorage Oncology Centre
🇺🇸Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
🇺🇸Anchorage, Alaska, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
🇺🇸Burbank, California, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Epic Care-Dublin
🇺🇸Dublin, California, United States
Bay Area Breast Surgeons Inc
🇺🇸Emeryville, California, United States
Epic Care Partners in Cancer Care
🇺🇸Emeryville, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Hematology and Oncology Associates-Oakland
🇺🇸Oakland, California, United States
Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Saint Mary Corwin Medical Center
🇺🇸Pueblo, California, United States
The Medical Center of Aurora
🇺🇸Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
🇺🇸Colorado Springs, Colorado, United States
Mercy Medical Center
🇺🇸Durango, Colorado, United States
Mountain Blue Cancer Care Center
🇺🇸Golden, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village
🇺🇸Greenwood Village, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
🇺🇸Englewood, Colorado, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
🇺🇸Littleton, Colorado, United States
Littleton Adventist Hospital
🇺🇸Littleton, Colorado, United States
Saint Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
🇺🇸Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
🇺🇸Lone Tree, Colorado, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Longmont United Hospital
🇺🇸Longmont, Colorado, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
Parker Adventist Hospital
🇺🇸Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker
🇺🇸Parker, Colorado, United States
Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Rocky Mountain Cancer Centers - Pueblo
🇺🇸Pueblo, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
🇺🇸Thornton, Colorado, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Medical Oncology Hematology Consultants PA
🇺🇸Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
🇺🇸Newark, Delaware, United States
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Christiana Gynecologic Oncology LLC
🇺🇸Newark, Delaware, United States
Beebe Health Campus
🇺🇸Rehoboth Beach, Delaware, United States
Oncare Hawaii Inc-Pali Momi
🇺🇸'Aiea, Hawaii, United States
Regional Hematology and Oncology PA
🇺🇸Newark, Delaware, United States
Florida Hospital Memorial Medical Center
🇺🇸Daytona Beach, Florida, United States
Pali Momi Medical Center
🇺🇸'Aiea, Hawaii, United States
Nanticoke Memorial Hospital
🇺🇸Sanford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
🇺🇸Wilmington, Delaware, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Oncare Hawaii Inc-POB II
🇺🇸Honolulu, Hawaii, United States
Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
The Cancer Center of Hawaii-Leeward
🇺🇸'Ewa Beach, Hawaii, United States
Straub Clinic and Hospital
🇺🇸Honolulu, Hawaii, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
Kuakini Medical Center
🇺🇸Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
🇺🇸Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Oncare Hawaii Inc-Kuakini
🇺🇸Honolulu, Hawaii, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii-Liliha
🇺🇸Honolulu, Hawaii, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
🇺🇸Fruitland, Idaho, United States
Saint Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian
🇺🇸Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
🇺🇸Twin Falls, Idaho, United States
Saint Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Memorial Hospital of Carbondale
🇺🇸Carbondale, Illinois, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Cancer Care Specialists of Central Illinois
🇺🇸Decatur, Illinois, United States
Advocate Sherman Hospital
🇺🇸Elgin, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Oconomowoc Memorial Hospital-ProHealth Care Inc
🇺🇸Oconomowoc, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Valley Radiation Oncology
🇺🇸Peru, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Illinois CancerCare-Peoria
🇺🇸Peoria, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Waukesha Memorial Hospital
🇺🇸Waukesha, Illinois, United States
Memorial Regional Cancer Center Day Road
🇺🇸Mishawaka, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Mary Greeley Medical Center
🇺🇸Ames, Iowa, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
McFarland Clinic PC-Boone
🇺🇸Boone, Iowa, United States
Physicians' Clinic of Iowa PC
🇺🇸Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center-Sioux City
🇺🇸Des Moines, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
🇺🇸Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
🇺🇸Jefferson, Iowa, United States
Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
McFarland Clinic PC-Marshalltown
🇺🇸Marshalltown, Iowa, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Methodist West Hospital
🇺🇸West Des Moines, Iowa, United States
Saint Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Hardin Memorial Hospital
🇺🇸Elizabethtown, Kentucky, United States
Baptist Health Corbin
🇺🇸Corbin, Kentucky, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Mercy Hospital-Joplin
🇺🇸Joplin, Missouri, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Botsford Hospital
🇺🇸Farmington, Michigan, United States
Mercy Clinic-Rolla-Cancer and Hematology
🇺🇸Rolla, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
🇺🇸Saint Louis, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Wayne Memorial Hospital
🇺🇸Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
🇺🇸Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
🇺🇸Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
🇺🇸Wilson, North Carolina, United States
Dayton NCI Community Oncology Research Program
🇺🇸Dayton, Ohio, United States
Central Vermont Medical Center
🇺🇸Berlin, Vermont, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Marshfield Clinic Cancer Center at Sacred Heart
🇺🇸Eau Claire, Wisconsin, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
Marshfield Clinic-Chippewa Center
🇺🇸Chippewa Falls, Wisconsin, United States
Cheyenne Regional Medical Center-West
🇺🇸Cheyenne, Wisconsin, United States
Edwards Comprehensive Cancer Center
🇺🇸Huntington, West Virginia, United States
Providence Regional Cancer System-Yelm
🇺🇸Yelm, Washington, United States
Green Bay Oncology at Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Saint Agnes Hospital/Agnesian Cancer Center
🇺🇸Fond Du Lac, Wisconsin, United States
Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Holy Family Memorial Hospital
🇺🇸Manitowoc, Wisconsin, United States
Marshfield Clinic-Minocqua Center
🇺🇸Minocqua, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
🇺🇸Rhinelander, Wisconsin, United States
Westfields Hospital/Cancer Center of Western Wisconsin
🇺🇸New Richmond, Wisconsin, United States
D N Greenwald Center
🇺🇸Mukwonago, Wisconsin, United States
Lakeview Medical Center-Marshfield Clinic
🇺🇸Rice Lake, Wisconsin, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
🇺🇸Rice Lake, Wisconsin, United States
Saint Nicholas Hospital
🇺🇸Sheboygan, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Marshfield Clinic-Wausau Center
🇺🇸Wausau, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Rocky Mountain Cancer Centers-Penrose
🇺🇸Colorado Springs, Colorado, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States