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
  Purpose

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


Condition Intervention
Male Breast Cancer
Nausea and Vomiting
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Proportion of patients achieving a complete response [ Time Frame: At 0-24 hours after weekly intravenous doxorubin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Hannah Linden Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00343863     History of Changes
Other Study ID Numbers: 6140, NCI-2010-00801
Study First Received: June 22, 2006
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Nausea
Vomiting
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Signs and Symptoms, Digestive
Skin Diseases
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Ondansetron
Palonosetron
Alkylating Agents
Anti-Anxiety Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antipruritics
Antipsychotic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 23, 2014