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

NCT02290470 | Unknown Phase 2

• 1 other identifier: Gineolanzapina
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Keywords

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  days 2-5 post-chemotherapy

Secondary Outcomes (1)

• Nausea scores

  up to 5 days

Other Outcomes (4)

• Proportion of patients achieving Complete Response

  up to 5 days

• Impact of nausea and vomiting on daily life activities

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

• Incidence of potential toxicities related to olanzapine

  up to 5 days

Study Arms (3)

olanzapine Days 1-3

EXPERIMENTAL

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: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

olanzapine+Dexamethasone d 1-3

EXPERIMENTAL

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: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

dexamethasone days 1-3

ACTIVE COMPARATOR

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: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine

Interventions

Olanzapine DRUG

* 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).

Also known as: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel

dexamethasone days 1-3; olanzapine Days 1-3; olanzapine+Dexamethasone d 1-3

Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine DRUG

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

dexamethasone days 1-3; olanzapine Days 1-3; olanzapine+Dexamethasone d 1-3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Istituto Nazionale dei Tumori

Milan, Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Olanzapine; Palonosetron; Dexamethasone; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Luigi Celio, MD

  Istituto tumori

  STUDY CHAIR

• Domenica Lorusso, MD

  Istituto tumori

  PRINCIPAL INVESTIGATOR

• Gabriella Saibene, PharmD

  Istituto Tumori

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Celio, MD

CONTACT

0039 02 2390; luigi.celio@istitutotumori.mi.it

trialcenter trialcenter

CONTACT

0039 02 2390; trialcenter@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: November 14, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

IT (1)