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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Count of Patients Achieving a Complete Response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: cyclophosphamide (Drug)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: dexamethasone (Drug)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: doxorubicin hydrochloride (Drug)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: quality-of-life assessment (Procedure)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: nausea and vomiting therapy (Procedure)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: management of therapy complications (Procedure)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: ondansetron hydrochloride (Drug)
Dexamethasone + Ondansetron IV on Day 1
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).
Intervention: survey administration (Other)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: palonosetron hydrochloride (Drug)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: cyclophosphamide (Drug)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: dexamethasone (Drug)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: doxorubicin hydrochloride (Drug)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: quality-of-life assessment (Procedure)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: nausea and vomiting therapy (Procedure)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: management of therapy complications (Procedure)
Dexamethasone + Palonosetron IV on Day 1
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).
Intervention: survey administration (Other)
Outcomes
Primary Outcomes
Count of Patients Achieving a Complete Response
Time Frame: At 0-24 hours after weekly intravenous doxorubin
Secondary Outcomes
- Side Effects of Antiemetic Medications Used(Up to 3 months)
- Severity of Nausea(Up to 3 months)
- 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)
- Number of Participants That Had First Administration of Rescue Medication Within 48 Hours(up to 48 hours of chemotherapy)
- Number of Doses of Rescue Medications Used(Days 1-7 of each cycle)
- Quality of Life(Up to 3 months)
Investigators
Hannah Linden
Principal Investigator
University of Washington