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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

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ClinicalTrials.gov Identifier: NCT02116530
Recruitment Status : Completed
First Posted : April 17, 2014
Results First Posted : April 10, 2017
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematopoietic/Lymphoid Cancer Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific Drug: Olanzapine Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) Other: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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 Start Date : August 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Drug: Olanzapine
oral

Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
oral or IV

Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
oral or IV
Active Comparator: 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
 Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
oral or IV

Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
oral or IV

Other: Placebo
oral


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Patients With no Nausea [ Time Frame: 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 :
  1. Median Nausea Scores [ Time Frame: 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).

  2. Proportion of Patients With Complete Response [ Time Frame: 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.

  3. Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire [ Time Frame: 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).

  4. Frequency of Rescue Medication [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116530


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Rudolph M. Navari, MD, PhD, FACP Indiana University School of Medicine South Bend
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02116530    
Other Study ID Numbers: A221301
NCI-2014-00446 ( Other Identifier: NCI Clinical Trial Reporting Program )
U10CA031946 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2014    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: May 7, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Cyclophosphamide
Doxorubicin
Ondansetron
Olanzapine
Aprepitant
Fosaprepitant
Palonosetron
Granisetron
Antiemetics
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal