A phase II trial of palonosetron and 1-day dexamethasone and 3-day aprepitant to prevent nausea and vomiting in patients receiving paclitaxel and carboplati

Not Applicable

• Conditions: patients receiving paclitaxel and carboplatin for gynecologic malignancies

• Registration Number: JPRN-UMIN000013082
• Lead Sponsor: ara Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-05
• Study Completion: 2016-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

1.Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus etc. 2.Patients with symptomatic brain metastasis. 3.Receiving antiseizure medications. 4.Severe ascites and / or pleural effusion. 5.Bowel obstruction. 6.Symptom of emesis. 7.Hypersensitivity to have a history aprepitant and / or palonosetron and / or other 5-HT3 receptor antagonists and / or Hypersensitivity to have a history dexamethazone. . 8.Receiving pimozide 9.Pregnancy or lactation. 10.Previous history of receiving aprepitant and / or palonosetron. 11.Patient who doesn't have ability or intention that cooperates for procedure of the study 12.Inappropriate patients for this study judged by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of delayed complete response (CR), defined as no vomiting with no rescue medication for 24-120 h from the start of the first cycle of paclitaxel and carboplatin.