Overview

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

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antiemetics
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Ondansetron
Palonosetron
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