Randomized, Double Blind, Parallel Group, Controlled with Placebo Study performed Under Internal Blind Conditions whose Purpose is to Examine the Safety, Tolerability and Efficacy of MK-0869 for the Prevention of Nausea and Vomiting Induced by Chemotherapy Associated with Administration of High doses of Cisplatin.
- Conditions
- -C80 Malignant neoplasm, without specification of siteMalignant neoplasm, without specification of siteC80
- Registration Number
- PER-009-01
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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 <3 hours.
• Premenopausal patients must accredit a negative pregnancy test with sensitivity of 25 IU in serum or urine in the Pre-study visit and agree to use an appropriate contraceptive method at least 14 days before, from start to finish , and at least 14 days after the last dose of study medication. Women who take oral contraceptives should agree to add a form of barrier contraception.
• The patient has a Kamofsky score of> 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.
• 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 <1 500 mm3 and Leukocyte count <3000 / mm3, Platelet count <100,000 / mm3, AST> 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method