Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005024
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2000-04-06
Brief Title:
Granisetron to Prevent Nausea and Vomiting After Chemotherapy in Patients With Malignant Disease
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Double-blind Multicenter Parallel Study Comparing the Efficacy and Safety of Kytril Tablets With Placebo in the Prevention of Nausea and Vomiting During the Days Following Administration of IV Cyclophosphamide-based or Carboplatin-based Chemotherapy in Patients With Malignant Disease
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antiemetic drugs such as granisetron may help to prevent nausea and vomiting in patients treated with chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of granisetron with that of a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant disease
PURPOSE Randomized phase III trial to compare the effectiveness of granisetron with that of a placebo in preventing nausea and vomiting after chemotherapy in patients who have malignant disease
Detailed Description:
OBJECTIVES I Compare the efficacy and safety of oral granisetron versus placebo in preventing nausea and vomiting during the 48 hours that begins 24 hours after administration of cyclophosphamide-based or carboplatin-based chemotherapy regimens in patients with malignant disease
OUTLINE This is a randomized double blind placebo controlled parallel multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive oral granisetron on day 0 at 60 minutes prior to the scheduled administration of IV cyclophosphamide or carboplatin or doxorubicin chemotherapy On days 1 and 2 patients receive oral granisetron at approximately the same time as on day 0 Arm II Patients receive oral granisetron on day 0 as in arm I On days 1 and 2 patients receive oral placebo at approximately the same time as the granisetron tablets were taken on day 0 Patients are followed between 5 and 11 days after the last dose of study medication
PROJECTED ACCRUAL A total of 434 patients 217 per arm will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled parallel multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive oral granisetron on day 0 at 60 minutes prior to the scheduled administration of IV cyclophosphamide or carboplatin or doxorubicin chemotherapy On days 1 and 2 patients receive oral granisetron at approximately the same time as on day 0 Arm II Patients receive oral granisetron on day 0 as in arm I On days 1 and 2 patients receive oral placebo at approximately the same time as the granisetron tablets were taken on day 0 Patients are followed between 5 and 11 days after the last dose of study medication
PROJECTED ACCRUAL A total of 434 patients 217 per arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1674 | None | None | None |
| UCLA-9904005 | None | None | None |
| SB-BRL43694A513 | None | None | None |