Status:
UNKNOWN
Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Nausea
Vomiting
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized, pilot study explores the activity of olanzapine with or without delayed dexamethasone for the prevention of delayed nausea and vomiting in women with gynecologic cancer receiving the ...
Detailed Description
The purpose of this study is to assess if the use of olanzapine can improve control of delayed nausea and vomiting in women receiving the combination of carboplatin and paclitaxel for a gynaecologic c...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented gynaecologic cancer
- Patients who are chemotherapy naive and scheduled to receive 1-day moderately emetogenic chemotherapy (carboplatin Area under Curve (AUC) 5 plus paclitaxel).
- Women, 18 years and older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate organ system function, defined as follows:
- bone marrow: absolute neutrophil count \>=1,500/L, platelets \>=100,000/L liver: bilirubin 1.5 x upper limit of normal (ULN); transaminases \<=2.5 x ULN kidney: creatinine \<=1.5 x ULN
- • Able to take oral medications
Exclusion
- psychiatric illness or social situation that would preclude study compliance
- history of central nervous system (e.g., brain metastases, seizure disorder)
- Positive pregnancy test just before registration.
- treatment with any anti-emetic medication from 24 hours to 5 days after treatment.
- treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days before or during protocol therapy.
- concurrent abdominal radiation therapy.
- concurrent quinolone antibiotic therapy.
- known hypersensitivity to olanzapine.
- vomiting and/or significant nausea (\>= Common Toxicity Criteria for Adverse Events (CTCAE) grade 2) within the 24 hours before beginning chemotherapy.
- another organic cause for nausea or vomiting unrelated to chemotherapy administration.
- chronic alcoholism (as determined by the investigator).
- known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous 6 months.
- history of uncontrolled diabetes mellitus.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT02290470
Start Date
April 1 2014
End Date
November 1 2015
Last Update
November 14 2014
Active Locations (1)
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1
Istituto Nazionale dei Tumori
Milan, Milan, Italy, 20133