Clinical trial NCT00343863
Conditions: Male Breast Cancer Nausea and Vomiting Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer
Sponsor: University of Washington
Start date: 2006-01-01; Completion date: 2010-12-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

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

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.

Arms: arm 1: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.

Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride). arm 2: All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.

Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Interventions: intervention 1: palonosetron hydrochloride intervention 2: cyclophosphamide intervention 3: dexamethasone intervention 4: doxorubicin hydrochloride intervention 5: quality-of-life assessment intervention 6: nausea and vomiting therapy intervention 7: management of therapy complications intervention 8: ondansetron hydrochloride intervention 9: survey administration
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally intervention 3: Given orally or IV intervention 4: Given IV intervention 5: Ancillary studies intervention 6: Given IV intervention 7: Given IV intervention 8: Given IV intervention 9: Ancillary studies

Protocol documents: