Clinical trial · Interventional
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Patient Population
Summary
Brief summary (as posted)
The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compazine | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Neurokinin-1 Receptor Antagonist (NK1-RA) | Drug | — | UNRESOLVED |
| Olanzapine | Drug | — | UNRESOLVED |
| Ondansetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Nk1-RA
- description
- Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
- interventionNames
- Drug: Ondansetron
- Drug: Dexamethasone
- Drug: Neurokinin-1 Receptor Antagonist (NK1-RA)
- Drug: Compazine
- type
- EXPERIMENTAL
- label
- Olanzapine
- description
- Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
- interventionNames
- Drug: Ondansetron
- Drug: Dexamethasone
- Drug: Olanzapine
- Drug: Compazine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of gynecologic malignancy * No chemotherapy in the last 12 months * Scheduled to receive Carboplatin (AUC\>=4) and Paclitaxel every three weeks * ECOG performance status 0 or 1 * English speaking * Willing and able to provide informed consent * Laboratory values within protocol-defined parameters * No vomiting in the 24 hours prior to initiating chemotherapy * If childbearing potential exists, negative pregnancy test within 7 days prior to registration Exclusion Criteria: * Significant cognitive compromise * History of CNS disease (e.g. brain metastases, seizure disorder, dementia) * Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK) * Concurrent radiotherapy treatment * Known hypersensitivity to olanzapine * Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months * History of diabetes mellitus on medication (insulin or oral glycemic agent) * Alcohol abuse / chronic alcoholism * History of closed angle glaucoma * Current enrollment in other clinical trials
References
Publications (0)
Data not yet available