Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

October 13, 2015 updated by: Joseph Roscoe

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
  • Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
  • Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

  • Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
  • Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
  • Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center and gender. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.

  • Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
  • Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
  • Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
  • Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.

PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

1021

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36695
        • MBCCOP - Gulf Coast
    • Illinois
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New York
      • East Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Manhassett, New York, United States, 11030
        • CCOP - North Shore University Hospital
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
    • Washington
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Have a diagnosis of cancer and be chemotherapy naive.
  • Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
  • Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
  • Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
  • For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
  • Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
  • Able to understand English

Exclusion criteria:

  • No symptomatic brain metastases
  • No concurrent or impending bowel obstruction
  • Regimens containing liposomal doxorubicin or cisplatin are not allowed.
  • No concurrent pimozide, terfenadine, astemizole, or cisapride
  • No concurrent doxorubicin hydrochloride liposome or cisplatin
  • No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Drug: placebo
Given orally
Drug: dexamethasone
Given orally or IV
Other Names:
  • Decadron
Drug: palonosetron hydrochloride
Given orally or IV
Other Names:
  • Aloxi
Drug: prochlorperazine
Given orally or IV
Other Names:
  • Compazine
Experimental: Arm II
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
Drug: placebo
Given orally
Drug: dexamethasone
Given orally or IV
Other Names:
  • Decadron
Drug: prochlorperazine
Given orally or IV
Other Names:
  • Compazine
Drug: granisetron hydrochloride
Given orally or IV
Other Names:
  • Kytril
Active Comparator: Arm III
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
Drug: placebo
Given orally
Drug: dexamethasone
Given orally or IV
Other Names:
  • Decadron
Drug: palonosetron hydrochloride
Given orally or IV
Other Names:
  • Aloxi
Drug: aprepitant
Given orally or IV
Other Names:
  • Emend
Experimental: Arm IV
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
Drug: placebo
Given orally
Drug: dexamethasone
Given orally or IV
Other Names:
  • Decadron
Drug: palonosetron hydrochloride
Given orally or IV
Other Names:
  • Aloxi
Drug: prochlorperazine
Given orally or IV
Other Names:
  • Compazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home Record: Severity of Delayed Nausea
Time Frame: average of day 1 afternoon, evening and night, and all of days 2 and 3
1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse
average of day 1 afternoon, evening and night, and all of days 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Roscoe

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Joseph A. Roscoe, PhD, James P. Wilmot Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000544841
  • U10CA037420 (U.S. NIH Grant/Contract)
  • URCC-U1105 (Other Identifier: University of Rochester)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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