A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regime

Not Applicable

• Conditions: malignant tumor(only solid tumor)

• Registration Number: JPRN-UMIN000036489
• Lead Sponsor: niversity of Shizuoka, School of Pharmaceutical Sciences

Brief Summary

The percentage of patients who achieved TC during the overall phase, the primary endpoint of this study was 31.3%. CR was achieved in 61.4%, 84.3%, and 65.1% of patients during the overall, acute, and delayed phases, respectively. The most frequently reported adverse event was anorexia. The primary endpoint was below the threshold and we could not find benefit in the dexamethasone-free regimen, but CR during the overall phase was similar to that of the conventional three-drug regimen.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Study Completion: 2021-04-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. 2) Patients taking systemic corticosteroid (oral and intravenous) except for inhaled or topical corticosteroid preparation 3) Patients having a clear vomiting symptom such as brain metastasis or gastrointestinal obstruction to the passage of foods 4) Patients with symptomatic ascites or pleural effusions requiring therapeutic puncture 5) Patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 6) Patients who have convulsive disorders requiring anticonvulsants therapy 7) Patients receieving adrenaline or pimozide 8) Patients who start taking opioids within 48 h prior to registration 9) Patients who received radiation therapy to abdomen or pelvis within 6 days prior to registration or will receive radiation therapy until 6 days after cisplatin administration 10) Patients regularly taking antiemetics other than study drugs 11) Patients who cannot be hospitalized after administration of cisplatin during 6 days 12) Pregnant, breastfeeding or expecting women or who do not wish to use contraception 13) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1 within 28 days before registration 14) Patients with smoking habit 15) Patients who are judged to be inappropriate for the study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Control (no vomiting/retching, no rescue medication, and no nausea) proportion within 120 hours after the initiation of cisplatin administration

Secondary Outcome Measures

Name	Time	Method
1. TC proportion during acute phase (0-24 h) and delayed phase (24-120 h) 2. Complete response (CR: no vomiting/retching, no rescue medication) proportion for the overall phase, the acute phase and the delayed phase 3. Complete control (CC: no vomiting/retching, no rescue medication, and no more than mild nausea) proportion for the overall phase, the acute phase and the delayed phase 4. The proportion of "no nausea" for the overall phase, the acute phase and the delayed phase 5. Time to treatment failure 6. Adverse events 7. Relationship between antiemetic efficacy and pharmacogenomic biomarkers (Exploratory analysis)