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

NCT00343863 | Completed Results

• 2 other identifiers: 6140NCI-2010-00801
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

Male Breast Cancer; Nausea and Vomiting; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Count of Patients Achieving a Complete Response

  At 0-24 hours after weekly intravenous doxorubin

Secondary Outcomes (8)

• 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

Study Arms (2)

Dexamethasone + Ondansetron IV on Day 1

ACTIVE COMPARATOR

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).

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

Dexamethasone + Palonosetron IV on Day 1

EXPERIMENTAL

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).

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; Other: survey administration

Interventions

palonosetron hydrochloride DRUG

Given IV

Also known as: Aloxi, RS 25259-197

Dexamethasone + Palonosetron IV on Day 1

cyclophosphamide DRUG

Given orally

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

dexamethasone DRUG

Given orally or IV

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

doxorubicin hydrochloride DRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

nausea and vomiting therapy PROCEDURE

Given IV

Also known as: antiemetic support, management of nausea and vomiting, nausea and vomiting management, therapy, nausea and vomiting, vomiting and nausea management

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

management of therapy complications PROCEDURE

Given IV

Also known as: complications of therapy, management of

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

ondansetron hydrochloride DRUG

Given IV

Also known as: GR 38032F, GR-C507/75, SN-307, Zofran

Dexamethasone + Ondansetron IV on Day 1

survey administration OTHER

Ancillary studies

Dexamethasone + Ondansetron IV on Day 1; Dexamethasone + Palonosetron IV on Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Nausea; Vomiting; Breast Neoplasms

Interventions

Palonosetron; Cyclophosphamide; Dexamethasone; Calcium Dobesilate; Doxorubicin; Therapeutics; Ondansetron

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dr. Hannah Linden
• Organization: University of Washington / Seattle Cancer Care Alliance

hmlinden@uw.edu

206-288-6989

Study Officials

• Hannah Linden

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 23, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)