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

NCT02532634 | Completed Phase 4

• 1 other identifier: KJH-2015-01
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 10

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.

Conditions

Cancer; Tumors

Keywords

ramosetron; palonosetron; chemotherapy induced nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• To compare the overall complete response (CR) of RAD to PAD (Overall CR defined as no emesis, no rescue medication, at cycle 1

  0-120 hours

Study Arms (2)

ramosetron, aprepitant, dexamethasone

EXPERIMENTAL

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

Drug: ramosetron, aprepitant, dexamethasone

palonosetron, aprepitant, dexamethasone

ACTIVE COMPARATOR

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

Drug: palonosetron, aprepitant, dexamethasone

Interventions

ramosetron, aprepitant, dexamethasone 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

Also known as: ramosetron(nasea), aprepitant(emend)

ramosetron, aprepitant, dexamethasone

palonosetron, aprepitant, dexamethasone 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

Also known as: palonosetron(aloxi), aprepitant(emend)

palonosetron, aprepitant, dexamethasone

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangdong Sacred Heart Hospital: lead
• The Catholic University of Korea: collaborator
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (10)

St. Vincent'S Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospita

Daejeon, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Neoplasms; Vomiting

Interventions

ramosetron; Aprepitant; Dexamethasone; Palonosetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jin-Hyoung Kang, Ph.D

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Jung Hye Kwon, PhD

  Kangdong Sacred Heart Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 26, 2015
• Study Start: August 19, 2015
• Primary Completion: May 8, 2018
• Study Completion: May 8, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

KR (10)