gynecologic cancer
Conditions
Interventions
repeat-dose fosaprepitant:fosaprepitantD1,D3+standard treatment
single-dose fosaprepitant:fosaprepitantD1+standard treatment
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Prior to participation in the trial, subjects should sign and date the informed consent form; 2.Ages 18-75 years; 3.ECOG performance status 0-1; 4.Primary gynecologic cancer confirmed by histopathologypatients were required and were expected to tolerate cisplatin-based concurrent radiotherapy; 5.The subjects shall have adequate organ function and meet the following laboratory indicators: a.When granulocyte colony stimulating factor was not used for the last 14 days, the absolute value of neutrophil (ANC) was >= 1.5 x 10^9/L. b.Platelets >= 100 x 10^9/L in the last 14 days without blood transfusion. c.Hemoglobin & GT in the absence of blood transfusion or erythropoietin in the last 14 days;9 g/dL. d.Total bilirubin = 60 ml/min; g.Good coagulation function, defined as international standard ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; h.Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range.If baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled. i.The myocardial enzyme spectrum is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality with no clinical significance is also allowed to be included). 6.For female subjects of childbearing age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required.Women of non-reproductive age were defined as having at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy; 7.If there is a risk of conception, all subjects (male or female) are required to use a contraceptive with an annual failure rate of less than 1% throughout the treatment period up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1.Women of childbearing age were not using any contraceptive methods to avoid pregnancy including pregnant or lactating women; 2.Patients currently receiving potent CYP3A inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nevirapine), CYP3A inducers (rifampin, carbamazepine, phenytoin, phenobarbital) or CYP3A4 substrate (pimozide, terfenadine, astemizole, cisapride), warfarin, and cannot stop or switch to other medicine before starting study. 3.Patients with severe organic lesions or vital organ failure, such as decompensated cardiac, hepatic, pulmonary or renal failure resulting in intolerance to treatment, patients with severe infections that cannot be controlled; 4.Patients with psychiatric or neurological disorders that interfere with patient adherence to the study protocol (eg, patients with medical records of active central nervous system (CNS) metastases or recent CNS hemorrhage, patients with epilepsy or those on psychotropic or sedative medications); 5.Patients received drugs with antiemetic activity within 24 h before receiving the first dose of study medication or nausea and vomiting happened before chemotherapy; 6.Patients with history of allergic reaction to NK1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone; 7.Patients participating or having participated in other antiemetic clinical studies within 2 weeks; 8.Patients who received radiotherapy to the head region within one week prior to the first dose of study medication; 9.Patients who have participated in this study and have received one cycle of chemotherapy and antiemetic medication to prevent nausea and vomiting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate (CRR) of vomiting in 7 days (0-168h) after chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| acute phase (0-72h) CRR;delayed phase (72-168h) CRR;the time to the first vomiting attack and the degree of vomiting;the time to the first rescue treatment and the proportion of patients rescued;the proportion of patients without significant nausea and the proportion of patients without nausea;AEs; | — |
Countries
China
Contacts
Public ContactHaitao Yin
Xuzhou Central Hospital
Outcome results
None listed