Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel
NCT ID: NCT02290470
Last Updated: 2014-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
81 participants
INTERVENTIONAL
2014-04-30
2015-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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)
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).
Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
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)
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).
Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
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
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).
Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
Interventions
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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).
Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Principal Investigators
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Luigi Celio, MD
Role: STUDY_CHAIR
Istituto tumori
Domenica Lorusso, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto tumori
Gabriella Saibene, PharmD
Role: PRINCIPAL_INVESTIGATOR
Istituto Tumori
Locations
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Istituto Nazionale dei Tumori
Milan, Milan, Italy
Countries
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Central Contacts
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Other Identifiers
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Gineolanzapina
Identifier Type: -
Identifier Source: org_study_id