DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Male Breast Cancer; Nausea and Vomiting; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

Intervention: palonosetron hydrochloride (Drug); cyclophosphamide (Drug); dexamethasone (Drug); doxorubicin hydrochloride (Drug); quality-of-life assessment (Procedure); nausea and vomiting therapy (Procedure); management of therapy complications (Procedure); ondansetron hydrochloride (Drug); survey administration (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Hannah Linden, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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

Clinical Details

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

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

Primary outcome: Proportion of patients achieving a complete response

Secondary outcome:

Proportion of patients achieving complete response

Number of emetic episodes daily

Time to first emetic episode

Time to first administration of rescue medication

Number of doses of rescue medications used

Side effects of antiemetic medications used

Severity of nausea

Quality of life

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States
Additional Information

Starting date: January 2006
Last updated: May 7, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015