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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

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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Olanzapine Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : April 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015


Arm Intervention/treatment
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)
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

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)
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

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Nausea scores [ Time Frame: up to 5 days ]
    • Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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]

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290470


Contacts
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Contact: Luigi Celio, MD 0039 02 2390 ext 2597 luigi.celio@istitutotumori.mi.it
Contact: trialcenter trialcenter 0039 02 2390 ext 3824 trialcenter@istitutotumori.mi.it

Locations
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Italy
Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Principal Investigator: Luigi Celio         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Study Chair: Luigi Celio, MD Istituto tumori
Principal Investigator: Domenica Lorusso, MD Istituto tumori
Principal Investigator: Gabriella Saibene, PharmD Istituto Tumori
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02290470    
Other Study ID Numbers: Gineolanzapina
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Nausea
Vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Dexamethasone acetate
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Olanzapine
Palonosetron
BB 1101
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Antipsychotic Agents