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

Not Applicable

Completed

• Conditions: Male Breast Cancer; Nausea and Vomiting; Stage IIIA Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer
• 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

• Registration Number: NCT00343863
• Lead Sponsor: University of Washington

Brief 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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2017-04-14
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-10
• Last Update Submitted: 2017-06-10
• Results First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dexamethasone + Palonosetron IV on Day 1	palonosetron hydrochloride	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	cyclophosphamide	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	dexamethasone	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	doxorubicin hydrochloride	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	quality-of-life assessment	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	nausea and vomiting therapy	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	management of therapy complications	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	ondansetron hydrochloride	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Ondansetron IV on Day 1	survey administration	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	dexamethasone	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	quality-of-life assessment	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	nausea and vomiting therapy	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	management of therapy complications	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	survey administration	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	cyclophosphamide	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).
Dexamethasone + Palonosetron IV on Day 1	doxorubicin hydrochloride	All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7. Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).

Primary Outcome Measures

Name	Time	Method
Count of Patients Achieving a Complete Response	At 0-24 hours after weekly intravenous doxorubin

Secondary Outcome Measures

Name	Time	Method
Side Effects of Antiemetic Medications Used	Up to 3 months
Severity of Nausea	Up to 3 months	Count of participants with severe nausea
Count of Patients Achieving Complete Response	At 24-120 hours after weekly intravenous doxorubicin
Number of Days With Emetic Episodes and Rescue Medicines	Up to 3 months
Number of Participants That Had Emesis Within 48 Hours of Chemotherapy	Up to 48 hours of chemotherapy	Count of patients that had emesis within 48 hours of chemotherapy
Number of Participants That Had First Administration of Rescue Medication Within 48 Hours	up to 48 hours of chemotherapy	Count of patients that had first administration of rescue medication within 48 Hours
Number of Doses of Rescue Medications Used	Days 1-7 of each cycle
Quality of Life	Up to 3 months

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States