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Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-Induced Nausea and Vomiting; Ovarian Cancer

Intervention: Aprepitant/Ramosetron/Dexamethasone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Duk Soo Bae, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center

Summary

The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.

Clinical Details

Official title: Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.

Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen

Secondary outcome:

Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy

Time to First Vomiting Episode or Use of Rescue Medication

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

Inclusion criteria 1. patient is over 18 years 2. ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy 3. Karnofsky score > 60 4. Life expectancy > 4 months Exclusion criteria 1. Any of following conditions (mentally incapacitated or emotional or psychiatric disorder, user of any illicit drugs, has an active infection, hypersensitivity to ramosetron or aprepitant) 2. Patients have received a nonapproved drug within last 4 weeks 3. abnormal laboratory values (AST > 2. 5 normal, ALT > 2. 5 normal, Bilirubin > 1. 5 normal, Creatinine > 1. 5 normal) 4. Antiemetic drugs within 48 hours of study 5. Benzodiazepine or opiate within 48 hours 6. CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide) 7. CYP3A4 inhibitors (clarithromycin, ketoconazole) 8. CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)

Locations and Contacts

Samsung Medical Center, Seoul, Korea, Republic of
Additional Information

Starting date: May 2010
Last updated: October 8, 2012

Page last updated: August 23, 2015

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