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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


N/A
18 Years
N/A
Not Enrolling
Both
Male Breast Cancer, Nausea and Vomiting, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients achieving a complete response

Outcome Time Frame:

At 0-24 hours after weekly intravenous doxorubin

Safety Issue:

No

Principal Investigator

Hannah Linden

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6140

NCT ID:

NCT00343863

Start Date:

January 2006

Completion Date:

December 2010

Related Keywords:

  • Male Breast Cancer
  • Nausea and Vomiting
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Breast Neoplasms
  • Nausea
  • Vomiting
  • Breast Neoplasms, Male

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109