Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343863
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2006-06-22
Brief Title:
Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Efficacy of Palonosetron in the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Following Dose Dense Adriamycin-Cyclophosphamide Chemotherapy in Early Stage Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
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 dexamethasone ondansetron hydrochloride and palonosetron hydrochloride may help lessen or prevent nausea and vomiting caused by chemotherapy
PURPOSE This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer
PURPOSE This clinical trial studies how well giving dexamethasone together with ondansetron hydrochloride or palonosetron hydrochloride works in preventing nausea and vomiting in patients receiving doxorubicin hydrochloride and cyclophosphamide for early stage breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the proportion of patients achieving a complete response CR defined as no emesis and no rescue medications in the 0-24 hour time period following weekly intravenous doxorubicin
SECONDARY OBJECTIVES
I To determine the proportion of patients achieving a complete response CR defined as no emesis and no rescue medications in the 24-120 hour time period following weekly intravenous doxorubicin
II To determine the proportion of patients achieving a complete response CR defined as no emesis and no rescue medications in the 0-120 hour time period following weekly intravenous doxorubicin
III To determine the number of emetic episodes daily and cumulatively for the 24-120 and 0-120 hour time periods
IV To determine the time to first emetic episode V To determine the time to first administration of rescue medication VI To determine the time to treatment failure time to first emetic episode or administration of rescue medication whichever occurred first
VII To determine the number of doses of rescue medications used VIII To determine the side effects of antiemetic medications used IX To determine theseverity of nausea X To evaluate quality of life
OUTLINE Patients are assigned to 1 of 2 treatment groups
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7
GROUP I Patients receive dexamethasone IV or orally and ondansetron IV on day 1 prior to each dose of doxorubicin hydrochloride
GROUP II Patients receive dexamethasone IV or orally and palonosetron IV on day 1 prior to each dose of doxorubicin hydrochloride
Treatment repeats every 7 days for 12-15 courses in the absence of disease progression or unacceptable toxicity
I To determine the proportion of patients achieving a complete response CR defined as no emesis and no rescue medications in the 0-24 hour time period following weekly intravenous doxorubicin
SECONDARY OBJECTIVES
I To determine the proportion of patients achieving a complete response CR defined as no emesis and no rescue medications in the 24-120 hour time period following weekly intravenous doxorubicin
II To determine the proportion of patients achieving a complete response CR defined as no emesis and no rescue medications in the 0-120 hour time period following weekly intravenous doxorubicin
III To determine the number of emetic episodes daily and cumulatively for the 24-120 and 0-120 hour time periods
IV To determine the time to first emetic episode V To determine the time to first administration of rescue medication VI To determine the time to treatment failure time to first emetic episode or administration of rescue medication whichever occurred first
VII To determine the number of doses of rescue medications used VIII To determine the side effects of antiemetic medications used IX To determine theseverity of nausea X To evaluate quality of life
OUTLINE Patients are assigned to 1 of 2 treatment groups
All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7
GROUP I Patients receive dexamethasone IV or orally and ondansetron IV on day 1 prior to each dose of doxorubicin hydrochloride
GROUP II Patients receive dexamethasone IV or orally and palonosetron IV on day 1 prior to each dose of doxorubicin hydrochloride
Treatment repeats every 7 days for 12-15 courses in the absence of disease progression or unacceptable toxicity
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-2010-00801 | REGISTRY | CTRP Clinical Trial Reporting Program | None |