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Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00343863
First received: June 22, 2006
Last updated: May 7, 2013
Last verified: May 2013

June 22, 2006
May 7, 2013
January 2006
December 2010   (final data collection date for primary outcome measure)
Proportion of patients achieving a complete response [ Time Frame: At 0-24 hours after weekly intravenous doxorubin ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00343863 on ClinicalTrials.gov Archive Site
  • Proportion of patients achieving complete response [ Time Frame: At 24-120 hours and 0-120 hours following weekly intravenous doxorubicin ] [ Designated as safety issue: No ]
  • Number of emetic episodes daily [ Time Frame: At 24-120 hours and 0-120 hours ] [ Designated as safety issue: No ]
  • Time to first emetic episode [ Time Frame: At 0 hours and continues until first episode ] [ Designated as safety issue: No ]
  • Time to first administration of rescue medication [ Time Frame: At 0 hours and continues until first administration ] [ Designated as safety issue: No ]
  • Number of doses of rescue medications used [ Time Frame: Days 1-7 of each cycle ] [ Designated as safety issue: No ]
  • Side effects of antiemetic medications used [ Time Frame: Days 1-7 of each cycle ] [ Designated as safety issue: No ]
  • Severity of nausea [ Time Frame: Days 1-7 of each cycle ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Days 1-7 of each cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer
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

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Male Breast Cancer
  • Nausea and Vomiting
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Drug: palonosetron hydrochloride
    Given IV
    Other Names:
    • Aloxi
    • RS 25259-197
  • Drug: cyclophosphamide
    Given orally
    Other Names:
    • CPM
    • CTX
    • Cytoxan
    • Endoxan
    • Endoxana
  • Drug: dexamethasone
    Given orally or IV
    Other Names:
    • Aeroseb-Dex
    • Decaderm
    • Decadron
    • DM
    • DXM
  • Drug: doxorubicin hydrochloride
    Given IV
    Other Names:
    • ADM
    • ADR
    • Adria
    • Adriamycin PFS
    • Adriamycin RDF
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Procedure: nausea and vomiting therapy
    Given IV
    Other Names:
    • antiemetic support
    • management of nausea and vomiting
    • nausea and vomiting management
    • therapy, nausea and vomiting
    • vomiting and nausea management
  • Procedure: management of therapy complications
    Given IV
    Other Name: complications of therapy, management of
  • Drug: ondansetron hydrochloride
    Given IV
    Other Names:
    • GR 38032F
    • GR-C507/75
    • SN-307
    • Zofran
  • Other: survey administration
    Ancillary studies
Arm I

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).

Interventions:
  • Drug: palonosetron hydrochloride
  • Drug: cyclophosphamide
  • Drug: dexamethasone
  • Drug: doxorubicin hydrochloride
  • Procedure: quality-of-life assessment
  • Procedure: nausea and vomiting therapy
  • Procedure: management of therapy complications
  • Drug: ondansetron hydrochloride
  • Other: survey administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a histologically confirmed diagnosis of primary breast carcinoma
  • Patient must be naive to chemotherapy at the time of enrollment
  • Patients must have prescribed weekly intravenous adriamycin (doxorubicin) and daily oral cyclophosphamide treatment for early breast cancer
  • The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • Patients must have a Karnofsky index of greater than or equal to 50%
  • Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator

Exclusion Criteria:

  • Receipt of investigational drug within 30 days before study entry
  • Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent (with the exception of administration of the palonosetron/dexamethasone infusion solution), including the following: 5-HT3 receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide (diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of Taxanes); all benzodiazepines; haloperidol, droperidol, tetrahydrocannabinol, or nabilone; any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone) (topical or inhaled preparations are allowed)
  • Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding chemotherapy
  • Ongoing vomiting from any organic etiology
  • Need to receive systemic corticosteroids, except: a) when defined as part of the chemotherapy regimen as a preventative measure for chemotherapy toxicities; b) topical or inhaled preparations; and/or c) when used as rescue medication during the study
  • Known contraindication to 5-HT3 receptor antagonists (including palonosetron) or dexamethasone
  • Need to receive radiotherapy during the study
  • Inability to understand or cooperate with study procedures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00343863
6140, NCI-2010-00801
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Hannah Linden Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP