Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer

NCT05403580 | Withdrawn Phase 3 FDA Drug

• 3 other identifiers: MC211002NCI-2022-0247821-011317
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase III trial compares olanzapine to placebo in decreasing nausea and vomiting in patients with cancer that has spread to other places in the body (advanced). Patients with advanced cancer may experience nausea and/or vomiting that is unrelated to chemotherapy or radiation. Giving olanzapine may help reduce nausea and increase appetite in patients who have advanced cancer.

Conditions

Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in nausea score

  Evaluated using Visual Analogue Scale. Nausea scores at baseline and after the first two days and the change scores, for the first 2 days, will be summarized using mean (standard deviation) and median (range). The change scores from baseline to the end of the first 2 days will be compared between arms using a two-sample t-test or a Wilcoxon rank sum test as appropriate. The difference in nausea change scores from baseline to 2 days post treatment initiation between the two arms will be estimated along with a 95% confidence interval.

  Baseline to 24 hours of treatment

Secondary Outcomes (4)

• Daily nausea and vomiting scores

  Up to 28 days

• Daily episodes of vomiting/retching (number and time)

  Up to 28 days

• Utilization of rescue therapy

  Up to 28 days

• Incidence of adverse events with olanzapine

  Up to 28 days

Study Arms (2)

Arm I (olanzapine)

EXPERIMENTAL

Patients receive olanzapine PO every night on days 1-28.

Drug: Olanzapine; Other: Questionnaire Administration

Arm II (placebo, olanzapine)

ACTIVE COMPARATOR

Patients receive placebo PO every night on days 1-2 and olanzapine PO every night on days 3-28.

Drug: Olanzapine; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Olanzapine DRUG

Given PO

Also known as: LY 170053, Zyprexa, Zyprexa Zydis

Arm I (olanzapine); Arm II (placebo, olanzapine)

Placebo Administration DRUG

Given PO

Arm II (placebo, olanzapine)

Questionnaire Administration OTHER

Ancillary studies

Arm I (olanzapine); Arm II (placebo, olanzapine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Histologically or cytologically-confirmed cancer in an advanced incurable stage
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Chronic nausea that has been present for at least one week (daily score \> 5, on a 0-10 visual analogue scale)
• Serum creatinine \< 2.0 mg/dl =\< 120 days prior to registration
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) values \< 3 times upper limits of normal =\< 120 days prior to registration
• Negative pregnancy test done =\< 14 days prior to registration, for persons of childbearing potential only
• Able to provide written informed consent
• Able to complete questionnaire(s) by themselves or with assistance

You may not qualify if:

• Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant persons
• Nursing persons
• Received chemotherapy or radiation within the prior 14 days (advanced cancer patients receiving hormonal therapy or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
• Receiving treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for =\< 30 days prior to registration or planned during protocol therapy (patients may have received prochlorperazine and other phenothiazines as prior anti-emetic therapy)
• Those with concurrent use of ethyol; severe cognitive compromise; concurrent use of amifostine; concurrent use of quinolone antibiotic therapy; known hypersensitivity to olanzapine; or have planned chemotherapy or radiation during the 7 days following study initiation
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection (including human immunodeficiency virus \[HIV\])
• Cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
• Psychiatric illness/social situations that would limit compliance with study requirements
• Inability to swallow oral formulations of the agent(s)
• Tube feeding or nasogastric tube

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Charles L Loprinzi

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 3, 2022
• Study Start: June 3, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05