Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone

NCT ID: NCT02532634

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-19
• Study Completion Date: 2018-05-08

Brief Summary

The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving highly emetogenic chemotherapy.

Detailed Description

Currently, palonosetron is the clinically preferred antiemetic for Chemotherapy-induced nausea and vomiting (CINV).However the best 5-hydroxytryptamine 3 receptor (5-HT3R) antagonists for use in a triple drug combination for high emetogenic chemotherapy(HEC) has not yet been determined in randomized trials. Previous anti-emetic guidelines stated that the anti-emetic activities of 5-HT3R antagonists were similar at equivalent doses. Based on the meta-analysis of various 5-HT3R antagonists in double regimens, the NCCN guideline has suggested palonosetron as a preferred 5-HT3R antagonist in the triple antiemetic drug combination. But in Asia, RAD is one of the most popular treatments for HEC-treated cancer patients. However, the lack of clinical studies has precluded the recommendation of RAD as a standard regimen for HEC-induced CINV. In two previous studies conducted in Korea, RAD regimen showed significant efficacy for prevention of CINV which is comparable to the efficacy reported from the studies evaluating with PAD regimen. If the efficacy of RAD regimen is evidently proven by this kind of randomized multicenter-trial, RAD regimen can be more recommended as a standard regimen for HEC-induced CINV.

Conditions

Cancer; Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ramosetron, aprepitant, dexamethasone

1. Ramosetron 0.3mg IV day1

2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3

3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4

Group Type: EXPERIMENTAL

ramosetron, aprepitant, dexamethasone

Intervention Type: DRUG

ramosetron 0.3 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

palonosetron, aprepitant, dexamethasone

1. Palonosetron 0.25mg IV day1

2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3

3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4

Group Type: ACTIVE_COMPARATOR

palonosetron, aprepitant, dexamethasone

Intervention Type: DRUG

palonosetron 0.25 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

Interventions

ramosetron, aprepitant, dexamethasone

ramosetron 0.3 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

Intervention Type: DRUG

palonosetron, aprepitant, dexamethasone

palonosetron 0.25 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4

Intervention Type: DRUG

Other Intervention Names

ramosetron(nasea); aprepitant(emend); palonosetron(aloxi); aprepitant(emend)

Eligibility Criteria

Inclusion Criteria

• The patient's age is ≥ 19 years old
• Histologically or cytologically confirmed solid tumor
• Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v2.0, 2014 anti-emesis). (Cisplatin dosage is over 50mg/m2, combination therapy is available with other chemotherapeutic agents and including lymphoma)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Available oral administration of study drugs
• Adequate organ functions as follows: 1) Hematologic - white blood cell count (WBC) ≥ 3000 microliter (microL) or Neutrophil≥ 1500 micro/L, Platelet ≥ 100,000/microL; 2) Serum Creatinine ≤ 1.5 times upper limit of normal; 3) Hepatic function - Total bilirubin, AST, ALT ≤2.5 times upper limit of normal, ALP ≤ 2 times upper limit of normal( except ALP increasing due to bone metastasis
• Patients with normal range of serum K, Mg and hold serum Ca over lower limit of normal range
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria

• Patients with severe Hypertension, severe Heart disease, congenital long QT syndrome, bradyarrhythmia severe kidney disease(serum creatinine≥3㎎/㎗), liver disease (AST, ALT ≥ 2.5 times of upper normal range, ALP ≥ 2 times of upper normal range)
• Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
• Patients who have nausea and vomiting within 1 week before chemotherapy
• Patients who should take steroid, antiemetics, antipsychotic agent including benzodiazepine, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors for the treatment of other diseases
• Patients with brain tumor, brain metastasis or seizure
• Patients receiving chemotherapy within 6 months before enrollment
• Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
• Patients who have known allergy or severe side effect on study drugs(5-HT3 antagonist and aprepitant)
• Pregnant or lactating women, or women who wish to become pregnant
• Patients with drug abuse, a mental disease and difficult to communicate with investigators
• Others whom the investigator judges inappropriate as subjects for this study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: collaborator

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: collaborator

Kangdong Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kwon, Jung Hye

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Hyoung Kang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Jung Hye Kwon, PhD

Role: STUDY_DIRECTOR

Kangdong Sacred Heart Hospital

Locations

St. Vincent'S Hospital

Suwon, Gyeonggi-do, South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Chungnam National University Hospita

Daejeon, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

KJH-2015-01

Identifier Type: -

Identifier Source: org_study_id