Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

NCT02933099 | Unknown Phase 3 DMC

• 1 other identifier: WuhanUHC
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response

  The primary endpoint is the rate of patients achieving a complete response(defined as no emetic episode and no use of rescue medication) during over all time (0 to 120 hours post chemotherapy)

  Up to 10 days

Secondary Outcomes (4)

• Acute Phase Response

  0 to 24 hours post chemotherapy

• Delayed Phase Response

  >24 to 10 days post chemotherapy

• Functional Living Index -Emesis (FLIE)

  Up to 10 days

• Safety and tolerability as measured by the incidence and severity of adverse

  Up to 10 days

Study Arms (2)

Aprepitant arm

EXPERIMENTAL

Aprepitant+palonosetron+dexamethasone

Drug: Aprepitant+palonosetron+dexamethasone

Control arm

ACTIVE COMPARATOR

palonosetron+dexamethasone

Drug: palonosetron+dexamethasone

Interventions

Aprepitant+palonosetron+dexamethasone DRUG

Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus palonosetron 0.25 mg IV and dexamethasone (20 mg orally on day 1 and 8 mg orally on days 2 and 3)

Also known as: PDA

Aprepitant arm

palonosetron+dexamethasone DRUG

Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: palonosetron 0.25 mg IV and dexamethasone (12 mg orally on day 1 and 8 mg orally on days 2 and 3)

Also known as: PD

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically or cytologically confirmed nasopharyngeal carcinoma
• Accept chemotherapy for the first time
• Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV)
• Written informed consent

You may not qualify if:

• regnant or breast-feeding
• Uncontrolled psychosis history
• Inability or unwillingness to understand or cooperate with study procedures
• Central nervous system tumors primary or secondary
• Concurrent abdominal radiotherapy
• History of uncontrolled diabetes mellitus
• Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
• Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
• Pre-existing nausea or vomiting
• Inadequate hematological function and abnormal liver and renal function.
• History of sensitivity to olanzapine
• Concurrent application of quinolone antibiotic therapy
• Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
• Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
• Concurrent application of systemic corticosteroids

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10