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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

* Drug: Olanzapine 10 mg oral
* Drug: Chemotherapy (carboplatin and paclitaxel). Patients will receive carboplatin and paclitaxel.
* Drug: Anti-emetic treatment (palonosetron; plus dexamethasone). Palonosetron (0.25 mg IV) on the day of chemotherapy plus dexamethasone (16 mg IV on the day of chemotherapy and 8 or 4 mg (depending on the experimental arm) oral on days 2 and 3 post-chemotherapy).

all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1

Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

Luigi Celio, MD

trialcenter trialcenter

Luigi Celio

Domenica Lorusso, MD

Gabriella Saibene, PharmD

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 combination of carboplatin and paclitaxel. Women treated with this regimen are particularly susceptible to chemotherapy-induced nausea and vomiting. Given anti-emetic prophylaxis with olanzapine may increase the control of delayed symptoms in women receiving carboplatin and paclitaxel.

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 cancer. Patients are randomized to one of three treatment arms. Please see the "Arms and Intervention" sections for more detailed information. The primary objective is to determine in each treatment group the proportion of patients achieving Complete Protection (CP; no vomiting, no rescue anti-emetics, and no more than mild nausea) during the delayed phase (days 2-5 post-chemotherapy) in the first chemotherapy cycle. The secondary objectives are:

1. To determine the proportion of patients achieving Complete Response (CR; no vomiting, and no rescue anti-emetics) during the acute (day 1 post-chemotherapy), delayed, and overall (days 1-5 post-chemotherapy) periods.
2. To determine the incidences of potential toxicities ascribed to olanzapine.
3. To assess the impact of nausea and vomiting on daily life activities in each treatment group.

Protocol treatment is to begin ≤14 days of registration. Patients will receive treatment on Days 1-3. Patients will be permitted to take rescue therapy of the treating investigator's choice based on the clinical circumstances. After completing treatment, patients will be monitored for side effects.

Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel

Olanzapine for the Prevention of Delayed Nausea and Vomiting in Patients With Gynecologic Cancers Receiving Carboplatin and Paclitaxel-based Chemotherapy and Guideline-directed Prophylactic Anti-emetics

• Proportion of patients achieving Complete Response, defined as no emetic episodes and no use of rescue anti-emetics measured by the Nausea and Vomiting Daily Diary/Questionnaire.

• Impact of nausea and vomiting on daily life activities as measured by the Functional Living Index-Emesis Questionnaire.

• Incidence of potential toxicities related to olanzapine as measured by the Nausea and Vomiting Daily Diary/Questionnaire. \[Time frame: \] \[Designated as safety issue: Yes\]

• Frequency of rescue anti-emetics measured by the Nausea and Vomiting Daily Diary/Questionnaire.

Proportion of patients achieving delayed Complete Protection, defined as no vomiting, no rescue anti-emetics, and no more than mild nausea measured by the Nausea and Vomiting Daily Diary/Questionnaire.

• Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel	NCT02290470	Nausea Vomiting	Olanzapine Palonosetron, D...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel	NCT02290470	Nausea Vomiting	Olanzapine Palonosetron, D...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Spots Global Cancer Trial Database for palonosetron, dexamethasone, carboplatin, paclitaxel, olanzapine