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

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00343863

Purpose

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.

Condition	Intervention
Breast Cancer Nausea and Vomiting	Drug: cyclophosphamide Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: ondansetron Drug: palonosetron hydrochloride Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nausea and Vomiting

Drug Information available for: Dexamethasone Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron RS 25233-197 Palonosetron Hydrochloride Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	57
Study Start Date:	January 2008
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343863

Locations

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Hannah M. Linden, MD

Seattle Cancer Care Alliance

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000475746, UWCC-UW-6140, UWCC-05-9579-H/D, FHCRC-6140, MGI-FHCRC-6140
Study First Received:	June 22, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00343863 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
stage I breast cancer
stage II breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones

Signs and Symptoms
Serotonin Antagonists
Neoplasms by Site
Therapeutic Uses
Antipruritics
Nausea
Ondansetron
Dermatologic Agents
Alkylating Agents
Breast Diseases
Dexamethasone acetate
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Skin Diseases
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 04, 2010