None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with SCH 619734 10 mg (4 capsules) PO, QD, 2 hours prior to the administration of the first chemotherapeutic agent (cisplatin-based chemotherapy ≥
This group will be treated with SCH 619734 Placebo PO, QD, 2 hours prior to the administration of the first chemotherapeutic agent (cisplatin-based chemotherapy ≥
70 mg / m2 IV) on day 1 of cycle 1, and on day 1 of all Subsequent cycles (Up to a maximum of 6 cycles). + 0.5 hours before chemotherapy, Ondansetron and Dexamethasone will be administered.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is 18 years of age or older. 2. Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (>=70 mg/m2). 3. Subject has a Karnofsky performance score of >=60. 4. Subject has a predicted life expectancy of >=3 months. 5. Subject has adequate bone marrow, kidney, and liver function. 6. Subject is able to read, understand, and complete the questionnaires.
Exclusion criteria
Exclusion criteria: 1. Any current treatment or medical history that would confound the results of the study or pose any unwarranted risk in administering study drug to the subject. 2. Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone. 3. Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6. 4. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion. 5. Subject has symptomatic primary or metastatic central nervous system disease. 6. Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to demonstrate the complete response, defined as absence of nausea, vomiting, or need for rescue medication in the 120 hours following the start of chemotherapy. Measure:Global complete response index. Timepoints:120 hours after the start of chemotherapy on day 1 of each of the 6 cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to demonstrate the complete response, defined as absence of nausea, vomiting or need for rescue medication in the first 24 hours (acute phase) and between 24 and 120 hours (prolonged phase). Measure:1) Complete response rate for the acute phase. 2) Complete response rate for the prolonged phase. Timepoints:First 24 hours (acute phase) and between 24 and 120 hours (prolonged phase). Following the start of chemotherapy on day 1 of each of the 6 cycles. ; Outcome name:Clinical evaluation: Where in general refers to the 120 hours after the start of chemotherapy, acute phase refers to the first 24 hours after the start of chemotherapy, prolonged phase refers to the time range between 24 and 120 hours after the start of chemotherapy. And where: 1) No vomiting: Absence of vomit and retching. 2) No nausea: Visual analog scale (VAS) from 0 to 100, with a result <5 mm. 3) No significant nausea: VAS <25 mm. 4) Total control: No emesis, no rescue medication and a maximum VAS <5 mm. 5) Complete protection: No emesis, no rescue medication and a maximum VAS <25 mm. 6) Impact on quality of life: FLIE questionnaire Measure:1) No vomiting in general. 2) No vomiting in the acute phase. 3) No vomiting in the prolonged phase. 4) No nausea in general. 5) No nausea in the acute phase. 6) No nausea in the prolonged phase. 7) No significant nausea in general. 8) No nausea in the acute phase. 9) No nausea in the prolonged phase. 10) Time until the first emesis or until the use of a rescue medication. 11) Total control in general. 12) Total control in the acute phase. 13) Total control in the prolonged phase. 14) Total protection in general. 15) Total protection in the acute phase. 16) General protection in the prolonged phase. 17) Impact of nausea and vomiting induced by chemotherapy (CINV) on quality of life. Timepoints:First 24 hours (acute phase), between 24 and 120 hours (prolonged phase) and in the first 120 | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Georgia, Greece, Guatemala, Honduras, Mexico, Russian Federation, Singapore, South Africa, Switzerland, Taiwan, Ukraine
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed