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Dexamethasone and Ondansetron or Palonosetron in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy for Early-Stage Breast Cancer

2014-08-27 03:43:50 | BioPortfolio

Summary

RATIONALE: Antiemetic drugs, such as dexamethasone, ondansetron, and palonosetron, may help lessen or prevent nausea and vomiting caused by chemotherapy.

PURPOSE: This clinical trial is studying how well giving dexamethasone together with ondansetron or palonosetron works in preventing nausea and vomiting in patients undergoing chemotherapy for early-stage breast cancer.

Description

OBJECTIVES:

Primary

- Determine the complete response (CR) rate, defined as no emesis and no rescue medications in the 0-24 hour time period after weekly intravenous doxorubicin hydrochloride, in patients with early-stage breast cancer treated with dexamethasone in combination with either ondansetron or palonosetron.

Secondary

- Determine the proportion of patients achieving CR, defined as no emesis and no rescue medications in the 24-120 hour time period after weekly intravenous doxorubicin hydrochloride.

- Determine the proportion of patients achieving CR, defined as no emesis and no rescue medications in the 0-120 hour time period after weekly intravenous doxorubicin hydrochloride.

- Determine the number of emetic episodes daily and cumulatively for the 24-120 and 0-120 hour time periods in these patients.

- Determine the time to first emetic episode in these patients.

- Determine the time to first administration of rescue medication in these patients.

- Determine the time to treatment failure, defined as the time to first emetic episode or administration of rescue medication, whichever occurs first, in these patients.

- Determine the number of doses of rescue medications used in these patients.

- Determine the side effects of this regimen in these patients.

- Determine the severity of nausea in these patients.

- Determine the quality of life of these patients.

OUTLINE: This is a multicenter study. The first 7 patients enrolled in the study are assigned to group 1. After treatment in group 1 is completed, subsequent patients enrolled in the study are assigned to group 2.

All patients receive metronomic chemotherapy comprising doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Treatment repeats every 7 days for 12-15 courses.

- Group 1: Patients receive standard antiemetic therapy comprising dexamethasone IV or orally and ondansetron IV prior to each dose of doxorubicin hydrochloride.

- Group 2: Patients receive dexamethasone IV or orally and palonosetron hydrochloride IV prior to each dose of doxorubicin hydrochloride.

Patients may receive rescue antiemetic medication after chemotherapy at the discretion of the investigator.

Quality of life is assessed at baseline and on day 5 of each course.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Breast Cancer

Intervention

cyclophosphamide, dexamethasone, doxorubicin hydrochloride, ondansetron, palonosetron hydrochloride, quality-of-life assessment

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
98109-1024

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:50-0400

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