Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone (RAPA)

Kangdong Sacred Heart Hospital

Status and phase

Completed

Phase 4

Conditions

Tumors

Cancer

Treatments

Drug: palonosetron, aprepitant, dexamethasone

Drug: ramosetron, aprepitant, dexamethasone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02532634

KJH-2015-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

292 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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