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

Primary Purpose

Nausea, Vomiting

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Olanzapine

Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

About this trial

This is an interventional supportive care trial for Nausea focused on measuring Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

olanzapine Days 1-3

olanzapine+Dexamethasone d 1-3

dexamethasone days 1-3

Arm Description

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

Outcomes

Primary Outcome Measures

Complete Protection

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.

Secondary Outcome Measures

Nausea scores

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

Full Information

NCT ID

NCT02290470

First Posted

May 22, 2014

Last Updated

November 11, 2014

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

1. Study Identification

Unique Protocol Identification Number

NCT02290470

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

November 2015 (Anticipated)

Study Completion Date

November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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 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: 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. To determine the incidences of potential toxicities ascribed to olanzapine. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea, Vomiting

Keywords

Nausea, Vomiting

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

olanzapine Days 1-3

Arm Type

Experimental

Arm Description

Arm Title

olanzapine+Dexamethasone d 1-3

Arm Type

Experimental

Arm Description

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)

Arm Title

dexamethasone days 1-3

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

Palonosetron, Dexamethasone, Carboplatin, Paclitaxel

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete Protection

Description

Time Frame

days 2-5 post-chemotherapy

Secondary Outcome Measure Information:

Title

Nausea scores

Description

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

Time Frame

up to 5 days

Other Pre-specified Outcome Measures:

Title

Proportion of patients achieving Complete Response

Description

• 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.

Time Frame

up to 5 days

Title

Impact of nausea and vomiting on daily life activities

Description

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

Time Frame

day 1 (pre-chemotherapy) and day 6 (post-chemotherapy)

Title

Incidence of potential toxicities related to olanzapine

Description

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

Time Frame

up to 5 days

Title

Frequency of rescue anti-emetics

Description

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

Time Frame

up to 5 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luigi Celio, MD

Phone

0039 02 2390

Ext

2597

luigi.celio@istitutotumori.mi.it

First Name & Middle Initial & Last Name or Official Title & Degree

trialcenter trialcenter

Phone

0039 02 2390

Ext

3824

trialcenter@istitutotumori.mi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luigi Celio, MD

Organizational Affiliation

Istituto tumori

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Domenica Lorusso, MD

Organizational Affiliation

Istituto tumori

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gabriella Saibene, PharmD

Organizational Affiliation

Istituto Tumori

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Nazionale dei Tumori

City

Milan

ZIP/Postal Code

20133

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luigi Celio

12. IPD Sharing Statement

Learn more about this trial

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

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