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

Condition(s) targeted: Breast Cancer; Nausea and Vomiting

Intervention: cyclophosphamide (Drug); dexamethasone (Drug); doxorubicin hydrochloride (Drug); ondansetron (Drug); palonosetron hydrochloride (Drug); quality-of-life assessment (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Hannah M. Linden, MD, Study Chair, Affiliation: Seattle Cancer Care Alliance

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.

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

Study design: Masking: Open Label, Primary Purpose: Supportive Care

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed primary breast carcinoma

- Early-stage disease

- Chemotherapy-naïve disease

- Must be planning to undergo chemotherapy comprising weekly intravenous doxorubicin

hydrochloride and daily oral cyclophosphamide

- No vomiting, retching, or grade 2-4 nausea in the 24 hours preceding chemotherapy

- No ongoing vomiting from any organic etiology

PATIENT CHARACTERISTICS:

- Karnofsky performance status 50-100%

- Patients with known mild to moderate hepatic, renal, or cardiovascular impairment may

be enrolled at the discretion of the investigator

- No known contraindication to 5-HT3 receptor antagonists (including palonosetron

hydrochloride) or dexamethasone

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 30 days since prior investigational drugs

- No other drugs with potential antiemetic effect within 24 hours prior to starting

chemotherapy, including any of the following:

- 5-HT3 receptor antagonists

- Dopamine-receptor antagonists (e. g., metoclopramide)

- Phenothiazine antiemetics (e. g., prochlorperazine, thiethylperazine, or

perphenazine)

- Diphenhydramine

- Diphenhydramine allowed if given for prophylactic treatment of

hypersensitivity reactions associated with the administration of taxanes

- Scopolamine

- Chlorpheniramine maleate

- Trimethobenzamide

- All benzodiazepines

- Haloperidol

- Droperidol

- Tetrahydrocannabinol

- Nabilone

- Any systemic corticosteroid (e. g., hydrocortisone, methylprednisolone, or

prednisone)

- Topical or inhaled preparations allowed

- No other concurrent systemic corticosteroids except for the following:

- Corticosteroids given as part of the chemotherapy regimen as a preventative

measure for chemotherapy toxicities

- Topical or inhaled preparations

- Corticosteroids used as rescue medication during the study

- No concurrent radiotherapy

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109-1024, United States; Recruiting
Clinical Trials Office - Fred Hutchinson Cancer Research Cente, Phone: 800-804-8824

Seattle Cancer Care Alliance, Seattle, Washington 98109-1023, United States; Recruiting
Clinical Trials Office - Seattle Cancer Care Alliance, Phone: 800-804-8824

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2006
Last updated: February 9, 2010