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Antiemetic Therapy With or Wi...

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

Last Updated: 2025-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-20

Study Completion Date

2017-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematopoietic/Lymphoid Cancer Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Olanzapine + Chemotherapy + Antiemetic treatment

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)

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

oral

Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)

Intervention Type DRUG

oral or IV

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

Intervention Type DRUG

oral or IV

Placebo + Chemotherapy + Antiemetic treatment

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

Group Type ACTIVE_COMPARATOR

Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)

Intervention Type DRUG

oral or IV

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

Intervention Type DRUG

oral or IV

Placebo

Intervention Type OTHER

oral

Interventions

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Olanzapine

oral

Intervention Type DRUG

Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)

oral or IV

Intervention Type DRUG

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

oral or IV

Intervention Type DRUG

Placebo

oral

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rudolph M. Navari, MD, PhD, FACP

Role: STUDY_CHAIR

Indiana University School of Medicine South Bend

Locations

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Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Alaska Regional Hospital

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Epic Care-Dublin

Dublin, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute

Oakland, California, United States

Site Status

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Mercy Medical Center

Durango, Colorado, United States

Site Status

Southwest Oncology PC

Durango, Colorado, United States

Site Status

Comprehensive Cancer Care and Research Institute of Colorado LLC

Englewood, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Mountain Blue Cancer Care Center

Golden, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Greenwood Village

Greenwood Village, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

Littleton Adventist Hospital

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Parker Adventist Hospital

Parker, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

Site Status

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Gynecologic Oncology LLC

Newark, Delaware, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Regional Hematology and Oncology PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

Nanticoke Memorial Hospital

Sanford, Delaware, United States

Site Status

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status

MedStar Georgetown University Hospital

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

Site Status

MedStar Washington Hospital Center

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

Site Status

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, United States

Site Status