Status:
WITHDRAWN
Olanzapine for the Treatment of Chronic Nausea and/or Vomiting in Patients With Advanced Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Advanced Malignant Solid Neoplasm
Hematopoietic and Lymphoid Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To conduct a confirmatory phase III double-blind randomized clinical trial to evaluate the ability of olanzapine to decrease nausea in patients with advanced-cancer associated n...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05403580
Start Date
June 3 2022
End Date
December 1 2024
Last Update
May 6 2024
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