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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290470
Recruitment Status : Unknown
Verified November 2014 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE May 22, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)		 Complete Protection [ Time Frame: days 2-5 post-chemotherapy ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)		 Nausea scores [ Time Frame: up to 5 days ]
• Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 11, 2014)
  • Proportion of patients achieving Complete Response [ Time Frame: up to 5 days ]
    • 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 [ Time Frame: day 1 (pre-chemotherapy) and day 6 (post-chemotherapy) ]
    • 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 [ Time Frame: up to 5 days ]
    • 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 [ Time Frame: up to 5 days ]
    • Frequency of rescue anti-emetics measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel
Official Title  ICMJE 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
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Nausea
  • Vomiting
Intervention  ICMJE
  • Drug: Olanzapine
    • 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).
    Other Names:
    • Palonosetron
    • Dexamethasone
    • Carboplatin
    • Paclitaxel
  • Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
    all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
Study Arms  ICMJE
  • Experimental: olanzapine 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)
    Interventions:
    • Drug: Olanzapine
    • Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
  • Experimental: olanzapine+Dexamethasone d 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 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)
    Interventions:
    • Drug: Olanzapine
    • Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
  • Active Comparator: dexamethasone days 1-3

    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
    Interventions:
    • Drug: Olanzapine
    • Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)		 81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290470
Other Study ID Numbers  ICMJE Gineolanzapina
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Luigi Celio, MD Istituto tumori
Principal Investigator: Domenica Lorusso, MD Istituto tumori
Principal Investigator: Gabriella Saibene, PharmD Istituto Tumori
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP