None listed
Conditions
Interventions
DAY 1: MK-0869 Oral (125 mg) + Intravenous Ondansetron (32 mg) + Oral Dexamethasone (12 mg) + Oral Dexamethasone (placebo).
DAY 2 and 3: MK-0869 Oral (80 mg in the morning) + Oral Dexamethasone (8 mg in the morning) + Placebo of oral dexamethasone (night).
DAY 4: Oral dexamethasone (8 mg in the morning) + oral dexamethasone placebo (night)
Group name:Group II Type of group
DAY 1: Placebo of MK-0869 Oral (125 mg) + Ondansetron Intravenous (32 mg) + Oral Dexamethasone (20 mg).
DAY 2 and 3: Placebo of MK-0869 Oral (80 mg in the morning) + Oral Dexamethasone (8 mg in the morning) + Oral Dexamethasone (8 mg at night).
DAY 4: Oral Dexamethasone (8 mg in the morning) + Oral Dexamethasone (8 mg at night)
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is an adult with an age of> 18 years. • The patient is expected to receive his or her first series of cisplatin chemotherapy for a histologically documented solid tumor at a dose of> 70 mg / m ^ administered in 60. • The patient has a life expectancy of> 3 months. • The patient is able to read, understand and complete the questionnaires and the study diary, including the questions that require a response according to the visual analog scale (VAS). • The patient understands the procedures and agrees to participate in the study by providing written informed consent.
Exclusion criteria
Exclusion criteria: • The patient is mentally incapacitated or has an important emotional or psychiatric disorder that in the opinion of the investigator prevents their admission to the study. • The patient currently uses illicit drugs or there is current evidence of alcohol consumption (as defined by the criteria mentioned in the DSM-IV) determined by the investigator. • The patient will receive a stem cell rescue therapy along with the course of cisplatin chemotherapy. • The patient will receive an unauthorized (investigational) drug during the last 4 weeks. • Abnormal laboratory values: - Absolute neutrophil count 2.5 X upper limit of normal, ALT> 2.5 X upper limit of the normal, Bilirubin> 1.5 x upper limit of normal, Creatinine> 1.5 x upper limit of normal • The patient has a history of diseases that, in the opinion of the investigator, could confuse the results of the study or represent an unjustified risk when administering the study drug to the patient. • The patient has an active infection (for example, pneumonia) or any uncontrolled disease (for example, diabetic ketoacidosis, gastrointestinal obstruction) except for a tumor that in the opinion of the investigator could confuse the results of the study or represent an unjustified risk in administering the Study drug to the patient. • The patient will receive a multi-day chemotherapy with cisplatin in a single cycle. • The patient will receive a chemotherapy of moderate or high emetogenicity (Hesketh Level 3 or higher, Appendix 2) 6 days before and / or after the day on which cisplatin infusion is performed • The patient has been treated with the following antiemetic agents within 48 hours of Day 1 of the Study: 5-HT3 antagonists (ondansetron, granisetron, dolasetron, or tropisetron), phenothiazines (eg, prochlorperazine, flufenacin, perphenazine, triethylperazine, or chlorpromazine) ), butyrophenones (for example, haloperidol or droperidol), benzamides (for example, metoclopramide or alizapride), domperidone, cannabinoids • The patient has started benzodiazepine therapy within 48 hours of Day 1 of the Study, except for single daily doses of triazolam, termazepam or midazolam. • The patient has initiated systemic corticosteroid therapy within 72 hours of Day 1 of the Study, except as described in the protocol or as premedication for patients receiving paclitaxel or docetaxel (see Appendix 4). Patients who are receiving daily chronic steroid therapy (> 72 hours) may enroll as long as the dose of steroids is not> 10 mg of prednisone daily or equivalent. • The patient has vomited and / or has retched within 24 hours before the start of the cisplatin infusion on Day 1 of the Study in Cycle 1. • The patient has received or will receive radiation therapy to the abdomen (this includes from the level of the diaphragm or below) or pelvis within 1 week before or between Days 1 to 6 of the Study in Cycle 1. • The patient has a primary or metastatic CNS tumor. • The patient takes or has taken within 7 days of Day 1 of the Study: terfenadine, cisapride, astemizole, clarithromycin (the use of azithromycin, erythromycin and roxithromycin is recommended), ketoconazole or itraconazole (the use of fluconazole is allowed), amifostine • The patient takes or has taken within 30 days of Day 1 of the Study: barbiturates, rifampicin or rifabutin, phenytoin or carbamazepine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Patients with absence of emesis, no use of rescue therapy and a maximum of <25 mm nausea in the VAS Measure:Percentage of patients reporting Complete Response Timepoints:0 to 120 hours after the initiation of cisplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Daily record of nausea using VAS, Physical examination, Questionnaire on FLIE Measure:Proportion of patients with: Complete Protection, Absence of Vomiting, Significant Absence of Nausea (VAS 108) Timepoints:0 to 120 hours after the initiation of cisplatin ; Outcome name:Absence of Significant Nausea from 25 to 120 hours Measure:Time to the first episode of vomit Timepoints:From 25 to 120 hours ; Outcome name:Patients with absence of emesis, no use of rescue therapy and a maximum of <25 mm nausea in the VAS Measure:Proportion of patients with complete response Timepoints:From 0 to 24, from 25 to 120 and from 0 to 120 hours ; Outcome name:Statistical review of adverse experiences, reasons for discontinuation due to adverse experiences, laboratory values, electrocardiograms, physical exams and vital signs. Measure:Safety and tolerability Timepoints:During all of the study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed