Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care, Treatment	Active	18 and over	NCI, Pharmaceutical / Industry	UWCC-UW-6140 UWCC-05-9579-H/D, FHCRC-6140, MGI-FHCRC-6140, NCT00343863

Objectives

Primary

1. 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

1. 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.
2. 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.
3. Determine the number of emetic episodes daily and cumulatively for the 24-120 and 0-120 hour time periods in these patients.
4. Determine the time to first emetic episode in these patients.
5. Determine the time to first administration of rescue medication in these patients.
6. 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.
7. Determine the number of doses of rescue medications used in these patients.
8. Determine the side effects of this regimen in these patients.
9. Determine the severity of nausea in these patients.
10. Determine the quality of life of these patients.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Hannah Linden, MD, Protocol chair		Ph: 206-288-6710

U.S.A.
Washington
	Seattle
	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
		Clinical Trials Office - Fred Hutchinson Cancer Research Center	Ph:  800-804-8824
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824

Registry Information
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
Trial Start Date		2008-01-29
Trial Completion Date		2010-08-14 (estimated)
Registered in ClinicalTrials.gov		NCT00343863
Date Submitted to PDQ		2006-03-22
Information Last Verified		2009-02-01
NCI Grant/Contract Number		CA15704

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