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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hematopoietic/Lymphoid Cancer; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: Olanzapine (Drug); Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) (Drug); Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) (Drug); Placebo (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Rudolph M. Navari, MD, PhD, FACP, Study Chair, Affiliation: Indiana University School of Medicine South Bend

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.

Clinical Details

Official title: Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Proportion of patients with no nausea, defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire

Secondary outcome:

Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire

Complete response, defined as no emetic episodes and no use of rescue medication measured by the Nausea and Vomiting Daily Diary/Questionnaire

Incidence of potential toxicities related to olanzapine as measured by the Nausea and Vomiting Daily Diary/Questionnaire

Frequency of rescue medication repeatedly measured by the Nausea and Vomiting Daily Diary/Questionnaire

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- 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)

Locations and Contacts

Alaska Breast Care and Surgery LLC, Anchorage, Alaska 99508, United States

Alaska Oncology and Hematology LLC, Anchorage, Alaska 99508, United States

Alaska Regional Hospital, Anchorage, Alaska 99508, United States

Alaska Women's Cancer Care, Anchorage, Alaska 99508, United States

Anchorage Associates in Radiation Medicine, Anchorage, Alaska 98508, United States

Anchorage Oncology Centre, Anchorage, Alaska 99508, United States

Anchorage Radiation Therapy Center, Anchorage, Alaska 99504, United States

Katmai Oncology Group, Anchorage, Alaska 99508, United States

Providence Alaska Medical Center, Anchorage, Alaska 99508, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California 91505, United States

Epic Care-Dublin, Dublin, California 94568, United States

Bay Area Breast Surgeons Inc, Emeryville, California 94608, United States

Epic Care Partners in Cancer Care, Emeryville, California 94608, United States

UC San Diego Moores Cancer Center, La Jolla, California 92093, United States

Contra Costa Regional Medical Center, Martinez, California 945553, United States

Alta Bates Summit Medical Center - Summit Campus, Oakland, California 94609, United States

Bay Area Tumor Institute, Oakland, California 94609, United States

Hematology and Oncology Associates-Oakland, Oakland, California 94609, United States

Saint Mary Corwin Medical Center, Pueblo, California 81004, United States

Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado 80012, United States

The Medical Center of Aurora, Aurora, Colorado 80012, United States

Boulder Community Hospital, Boulder, Colorado 80301, United States

Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado 80304, United States

Penrose-Saint Francis Healthcare, Colorado Springs, Colorado 80901, United States

Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado 80907, United States

Colorado Blood Cancer Institute, Denver, Colorado 80907, United States

Exempla Saint Joseph Hospital, Denver, Colorado 80218, United States

Porter Adventist Hospital, Denver, Colorado 80210, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado 80218, United States

Rocky Mountain Cancer Centers-Midtown, Denver, Colorado 80218, United States

Rocky Mountain Cancer Centers-Rose, Denver, Colorado 80220, United States

Rose Medical Center, Denver, Colorado 80220, United States

Mercy Medical Center, Durango, Colorado 81301, United States

Southwest Oncology PC, Durango, Colorado 81301, United States

Comprehensive Cancer Care and Research Institute of Colorado LLC, Englewood, Colorado 80113, United States

Swedish Medical Center, Englewood, Colorado 80113, United States

Mountain Blue Cancer Care Center, Golden, Colorado 80401, United States

North Colorado Medical Center, Greeley, Colorado 80631, United States

Rocky Mountain Cancer Centers-Greenwood Village, Greenwood Village, Colorado 80111, United States

Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado 80228, United States

Saint Anthony Hospital, Lakewood, Colorado 80228, United States

Littleton Adventist Hospital, Littleton, Colorado 80122, United States

Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado 80120, United States

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado 80124, United States

Sky Ridge Medical Center, Lone Tree, Colorado 80124, United States

Longmont United Hospital, Longmont, Colorado 80501, United States

Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado 80501, United States

McKee Medical Center, Loveland, Colorado 80539, United States

Parker Adventist Hospital, Parker, Colorado 80138, United States

Rocky Mountain Cancer Centers-Parker, Parker, Colorado 80138, United States

Rocky Mountain Cancer Centers - Pueblo, Pueblo, Colorado 81008, United States

Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado 80260, United States

Exempla Lutheran Medical Center, Wheat Ridge, Colorado 80033, United States

Saint Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States

Beebe Medical Center, Lewes, Delaware 19958, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware 19718, United States

Christiana Gynecologic Oncology LLC, Newark, Delaware 19713, United States

Delaware Clinical and Laboratory Physicians PA, Newark, Delaware 19713, United States

Helen F Graham Cancer Center, Newark, Delaware 19713, United States

Medical Oncology Hematology Consultants PA, Newark, Delaware 19713, United States

Regional Hematology and Oncology PA, Newark, Delaware 19713, United States

Beebe Health Campus, Rehoboth Beach, Delaware 19971, United States

Nanticoke Memorial Hospital, Sanford, Delaware 19973, United States

Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware 19801, United States

MedStar Georgetown University Hospital, Washington, District of Columbia 20007, United States

MedStar Washington Hospital Center, Washington, District of Columbia 20010, United States

Florida Hospital Memorial Medical Center, Daytona Beach, Florida 32117, United States

Phoebe Putney Memorial Hospital, Albany, Georgia 31701, United States

Oncare Hawaii Inc-Pali Momi, Aiea, Hawaii 96701, United States

Pali Momi Medical Center, Aiea, Hawaii 96701, United States

The Cancer Center of Hawaii-Leeward, Ewa Beach, Hawaii 96706, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States

Kuakini Medical Center, Honolulu, Hawaii 96817, United States

Oncare Hawaii Inc-Kuakini, Honolulu, Hawaii 96817, United States

Oncare Hawaii Inc-POB II, Honolulu, Hawaii 96813, United States

OnCare Hawaii-Liliha, Honolulu, Hawaii 96817, United States

Queen's Medical Center, Honolulu, Hawaii 96813, United States

Straub Clinic and Hospital, Honolulu, Hawaii 96813, United States

The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii 96817, United States

Tripler Army Medical Center, Honolulu, Hawaii 96859, United States

University of Hawaii Cancer Center, Honolulu, Hawaii 96813, United States

Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii 96766, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho 83706, United States

Saint Luke's Mountain States Tumor Institute, Boise, Idaho 83712, United States

Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho 83619, United States

Saint Luke's Mountain States Tumor Institute - Meridian, Meridian, Idaho 83642, United States

Saint Luke's Mountain States Tumor Institute - Nampa, Nampa, Idaho 83686, United States

Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho 83301, United States

Saint Joseph Medical Center, Bloomington, Illinois 61701, United States

Memorial Hospital of Carbondale, Carbondale, Illinois 62902, United States

Cancer Care Specialists of Central Illinois, Decatur, Illinois 62526, United States

Decatur Memorial Hospital, Decatur, Illinois 62526, United States

Advocate Sherman Hospital, Elgin, Illinois 60123, United States

Illinois CancerCare Galesburg, Galesburg, Illinois 61401, United States

Western Illinois Cancer Treatment Center, Galesburg, Illinois 61401, United States

Ingalls Memorial Hospital, Harvey, Illinois 60426, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois 62864, United States

Oconomowoc Memorial Hospital-ProHealth Care Inc, Oconomowoc, Illinois 53066, United States

Illinois CancerCare-Peoria, Peoria, Illinois 61615, United States

Methodist Medical Center of Illinois, Peoria, Illinois 61603, United States

OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States

Valley Radiation Oncology, Peru, Illinois 61354, United States

OSF Saint Anthony Medical Center, Rockford, Illinois 61108, United States

Memorial Medical Center, Springfield, Illinois 62781, United States

Southern Illinois University School of Medicine, Springfield, Illinois 62702, United States

Waukesha Memorial Hospital, Waukesha, Illinois 53188, United States

Memorial Regional Cancer Center Day Road, Mishawaka, Indiana 46544, United States

Memorial Hospital of South Bend, South Bend, Indiana 46601, United States

Mary Greeley Medical Center, Ames, Iowa 50010, United States

McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa 50010, United States

McFarland Clinic PC-Boone, Boone, Iowa 50036, United States

Mercy Hospital, Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa 52403, United States

Physicians' Clinic of Iowa PC, Cedar Rapids, Iowa 52402, United States

Iowa Lutheran Hospital, Des Moines, Iowa 50316, United States

Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States

Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa 50309, United States

Mercy Medical Center-Sioux City, Des Moines, Iowa 51102, United States

McFarland Clinic PC-Trinity Cancer Center, Fort Dodge, Iowa 50501, United States

McFarland Clinic PC-Jefferson, Jefferson, Iowa 50129, United States

McFarland Clinic PC-Marshalltown, Marshalltown, Iowa 50158, United States

Mercy Medical Center - North Iowa, Mason City, Iowa 50401, United States

Saint Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

Siouxland Regional Cancer Center, Sioux City, Iowa 51101, United States

Methodist West Hospital, West Des Moines, Iowa 50266, United States

Baptist Health Corbin, Corbin, Kentucky 40701, United States

Hardin Memorial Hospital, Elizabethtown, Kentucky 42701, United States

Baptist Health Lexington, Lexington, Kentucky 40503, United States

Newton-Wellesley Hospital, Newton, Massachusetts 02462, United States

Botsford Hospital, Farmington, Michigan 48336, United States

William Beaumont Hospital - Troy, Troy, Michigan 48098, United States

Mercy Hospital-Joplin, Joplin, Missouri 64804, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri 65401, United States

Phelps County Regional Medical Center, Rolla, Missouri 65401, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri 63141, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri 63109, United States

CoxHealth South Hospital, Springfield, Missouri 65807, United States

Mercy Hospital Springfield, Springfield, Missouri 65804, United States

Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina 28328, United States

Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina 27534, United States

Wayne Memorial Hospital, Goldsboro, North Carolina 27534, United States

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina 28546, United States

Southeastern Medical Oncology Center-Wilson, Wilson, North Carolina 27893, United States

Dayton NCI Community Oncology Research Program, Dayton, Ohio 45420, United States

Miriam Hospital, Providence, Rhode Island 02906, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Central Vermont Medical Center, Berlin, Vermont 05602, United States

University of Vermont College of Medicine, Burlington, Vermont 05405, United States

Providence Regional Cancer System-Yelm, Yelm, Washington 98597, United States

Edwards Comprehensive Cancer Center, Huntington, West Virginia 25701, United States

Cheyenne Regional Medical Center-West, Cheyenne, Wisconsin 82001, United States

Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin 54729, United States

Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin 54701, United States

Saint Agnes Hospital/Agnesian Cancer Center, Fond Du Lac, Wisconsin 54935, United States

Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin 54301, United States

Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin 54303, United States

Saint Mary's Hospital, Green Bay, Wisconsin 54303, United States

Saint Vincent Hospital, Green Bay, Wisconsin 54301, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin 54601, United States

Holy Family Memorial Hospital, Manitowoc, Wisconsin 54221, United States

Bay Area Medical Center, Marinette, Wisconsin 54143, United States

Marshfield Clinic, Marshfield, Wisconsin 54449, United States

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin 54548, United States

D N Greenwald Center, Mukwonago, Wisconsin 53149, United States

Westfields Hospital/Cancer Center of Western Wisconsin, New Richmond, Wisconsin 54017, United States

Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin 54154, United States

Marshfield Clinic at James Beck Cancer Center, Rhinelander, Wisconsin 54501, United States

Lakeview Medical Center-Marshfield Clinic, Rice Lake, Wisconsin 54868, United States

Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin 54868, United States

William Beaumont Hospital-Royal Oak, Royal Oak, Wisconsin 48073, United States

Saint Nicholas Hospital, Sheboygan, Wisconsin 53081, United States

Marshfield Clinic Cancer Care at Saint Michael's Hospital, Stevens Point, Wisconsin 54481, United States

Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States

Marshfield Clinic-Wausau Center, Wausau, Wisconsin 54401, United States

Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin 54494, United States

Additional Information

Starting date: August 2014
Last updated: June 15, 2015

Page last updated: August 23, 2015

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