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

• Status: Completed
• Trial end date: 2018-05-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kangdong Sacred Heart Hospital
• Collaborators: Astellas Pharma Korea, Inc.; The Catholic University of Korea
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Palonosetron; Ramosetron

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