NCT00343863

Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Male Breast Cancer
• Nausea and Vomiting
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer

Interventions

Type	Name	Description
DRUG	palonosetron hydrochloride	Given IV
DRUG	cyclophosphamide	Given orally
DRUG	dexamethasone	Given orally or IV
DRUG	doxorubicin hydrochloride	Given IV
PROCEDURE	quality-of-life assessment	Ancillary studies
PROCEDURE	nausea and vomiting therapy	Given IV
PROCEDURE	management of therapy complications	Given IV
DRUG	ondansetron hydrochloride	Given IV
OTHER	survey administration	Ancillary studies

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2006-06-23
• Last updated: 2017-07-11
• Results posted: 2017-07-11

Locations

1 site across 1 country: United States