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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
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
May 22, 2014
Last Updated
November 11, 2014
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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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
No

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
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)
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
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
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
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.
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
No
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
Email
luigi.celio@istitutotumori.mi.it
First Name & Middle Initial & Last Name or Official Title & Degree
trialcenter trialcenter
Phone
0039 02 2390
Ext
3824
Email
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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