Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel
Nausea, Vomiting
About this trial
This is an interventional supportive care trial for Nausea focused on measuring Nausea, Vomiting
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Istituto Nazionale dei TumoriRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
olanzapine Days 1-3
olanzapine+Dexamethasone d 1-3
dexamethasone days 1-3
Olanzapine + Chemotherapy + Antiemetic treatment Patients will receive the chemotherapy drugs carboplatin and paclitaxel as well as the following anti-nausea/vomiting drugs: Palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (16 mg intravenously on the day of chemotherapy), plus Olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3 post chemotherapy)
Olanzapine + Chemotherapy + Antiemetic treatment Patients will receive the chemotherapy drugs carboplatin and paclitaxel as well as the following anti-nausea/vomiting drugs: Palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone (16 mg intravenously on the day of chemotherapy and 4 mg orally days 2, 3 post chemotherapy), plus Olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3 post chemotherapy)
Dexamethasone + Chemotherapy + Antiemetic treatment Patients will receive the chemotherapy drugs carboplatin and paclitaxel as well as usual anti-nausea/vomiting drugs: Palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus Dexamethasone 16 mg intravenously on the day of chemotherapy (day 1), plus Dexamethasone 8 mg orally on days 2 and 3 post chemotherapy