NauseaPhase 2NCT02290470
Olanzapine Against Delayed Nausea and Vomiting in Women Receiving Carboplatin Plus Paclitaxel
A Phase 2 study testing Olanzapine and Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine in people with Nausea and Vomiting, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Olanzapine and Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale dei Tumori
Milan, Milan, 20133
Luigi Celio
About this study
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
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.
Read the 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.
- Being tested
- Olanzapine, Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine
- Keywords
- Nausea, Vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Palonosetron, Dexamethasone, Carboplatin, Paclitaxel
- 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, OlanzapineDrug
all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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 Receives: Drug: Olanzapine; Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: days 2-5 post-chemotherapy
Secondary outcomes (1)
Nausea scores
- Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Celio, MD, Study chair, Istituto tumoriDomenica Lorusso, MD, Principal investigator, Istituto tumoriGabriella Saibene, PharmD, Principal investigator, Istituto Tumori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290470
- Sponsor's protocol ID
- Gineolanzapina
- Status last verified
- Nov 2014
- First submitted
- 22 May 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02290470
- Acronym / sponsor ID
- Gineolanzapina
- Keywords
- Nausea, Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| olanzapine Days 1-3 | Experimental | Drug: Olanzapine, Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, OlanzapineOlanzapine + 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+Dexamethasone d 1-3 | Experimental | Drug: Olanzapine, Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, OlanzapineOlanzapine + 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 days 1-3 | Active comparator | Drug: Olanzapine, Drug: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, OlanzapineDexamethasone + 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: Palonosetron, Dexamethasone, Carboplatin, Paclitaxel* 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). | Drug | dexamethasone days 1-3, olanzapine Days 1-3, olanzapine+Dexamethasone d 1-3 |
| Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapineall patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1 | Drug | dexamethasone days 1-3, olanzapine Days 1-3, olanzapine+Dexamethasone d 1-3 |
Primary outcome
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.
1 secondary outcome
Nausea scores
Time frame: up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Celio, MD study chair
Istituto tumori
Domenica Lorusso, MD principal investigator
Istituto tumori
Gabriella Saibene, PharmD principal investigator
Istituto Tumori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olanzapine and Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine in people with Nausea and Vomiting, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Celio, MD (0039 02 2390 ext. 2597, luigi.celio@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Protection (time frame: days 2-5 post-chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.