None listed
Conditions
Interventions
Patients will be subjected to one of the following chemotherapy regimens, in cycles of 14 days or 21 - 28 days:
1) Regimen # 1: Cyclophosphamide IV (500-1500 mg / m2) and Doxorubicin IV (≥
40 mg / m2).
2) Regimen # 2: Cyclophosphamide IV (500-1500 mg / m2) and Epirubicin IV (≥
ARM 4 Type of group
60 mg / m2)
This group will be treated with Ondansetron 8 mg, PO, BID, for 3 days after chemotherapy + Casopitant Placebo, PO, QD, the first day after chemotherapy + Casopitant 50 mg, PO, QD, days
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject understands the nature and purpose of this study and its procedures, and has signed an informed consent form to indicate it. 2. You are at least 18 years of age. 3. You have been scheduled to receive your first cycle of a moderately emetogenic chemotherapy regimen containing anthracycline and cyclophosphamide for the treatment of a malignant solid tumor. 4. Has an ECOG performance status of 0, 1, or 2. 5. The hematological and metabolic status must be adequate to receive a moderately emetogenic regimen and must meet the following criteria: a) Total Neutrophils ≥ 1500 / mm3. b) Platelets ≥ 100,000 / mm3. c) Bilirubin ≤ 1.5 x ULN. d) Liver enzymes should be below the following normal limits. 6. The subject is willing and able to complete daily the components of the subject´s diary for each cycle of the study. 7. Women of reproductive age should commit to the consistent and correct use of an acceptable method of birth control.
Exclusion criteria
Exclusion criteria: 1. Patient has previously received cytotoxic chemotherapy. 2. It is a female subject who is pregnant or breastfeeding. 3. Patient has received radiation therapy in the brain, abdomen or pelvis during the ten days prior to the first dose of study medication and / or will receive radiation therapy in the brain, abdomen or pelvis for six days after the first dose of the study medication. 4. Patient is scheduled to receive therapy with taxanes during cycle 1. 5. You have experienced clinically significant emesis or nausea during the 24 hours before the first dose of the study medication. 6. It has a known primary or metastatic malignancy in the central nervous system. 7. Has a documented history of peptic ulcer, active peptic ulcer, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition that may confuse the results of the study, represent another potential etiology for emesis and nausea, or pose an unwarranted risk for the subject. 8. Presents hypersensitivity or a known contraindication to ZOFRAN, to another 5-HT3 antagonist receptor, to dexamethasone or to any component of casopitant. 9. Previously, he has received an antagonist receptor for NK-1. 10. Received a research drug during the previous 30 days or is scheduled to receive a research drug other than casopitant during the study period. 11. Took / received any medication with moderately or highly emetogenic potential within 48 hours prior to the first dose of the study medication. 12. Took / received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving the study medication. 13. Took / received strong or moderate inhibitors of CYP3A4 and CYP3A5 during a specific period prior to the administration of the investigational product. 14. Took / received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of the investigational product. 15. You are taking the antidiabetic agent repaglinide or the diuretic torasemide. 16. You are currently taking or considering taking any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of the complete response, defined as the absence of vomiting / arcades and rescue therapy. Measure:Proportion of subjects that reach a complete response. Timepoints:At 120 hours after the start of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of the complete response, defined as the absence of vomiting / arcades and rescue therapy. The phases are defined according to the time that has passed since the start of chemotherapy: Acute (0-24 h), late (24-120 h) and global (0-120 h). Maximum score of nausea: Evaluated with a Visual Analogue Scale (VAS). Clinical evaluation to determine the time elapsed between the start of the administration of the medication and the appearance of an emetic episode and / or the administration of a rescue medication. Measure:1) Proportion of subjects that reach a complete response during the acute and late phase. 2) Proportion of subjects that achieve a complete response during the acute, late, and global phases. 3) Maximum score of nausea. 4) Time until the first rescue medication. 5) Time until the first emetic event. Timepoints:At 0, 24 and 120 hours after the start of therapy. ; Outcome name:Visual analogue rating (VAS) scales will be used for the assessment of nausea and its intensity. The clinical evaluation will evaluate the number of subjects who achieved complete protection (complete response who have not had significant nausea), total control (complete response who have not had nausea). Impact on daily activities: FLIE questionnaire. Satisfaction of the subjects: Evaluation of Satisfaction / Will, in the Diary of the Subject. Measure:1) Proportion of subjects receiving rescue medication. 2) Proportion of subjects who vomit / have retching. 3) Proportion of subjects reporting significant nausea. 4) Proportion of subjects reporting nausea. 5) Proportion of subjects that achieve complete protection. 6) Proportion of subjects that obtain total control. 7) Impact on daily activities. 8) Satisfaction of the subjects. 9) Nausea. Timepoints:At 120 hours after the start of chemotherapy. ; Outcome name:Routine physical exam. Laboratory tests: Hematological and chemical panels, urine test. | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Germany, Hungary, India, Ireland, Italy, Korea South, Latovia, Lithuania, Mexico, Pakistan, Peru, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kindgdom, United States
Outcome results
None listed