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

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ClinicalTrials.gov Identifier: NCT00475085
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : November 4, 2013
Last Update Posted : November 10, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester NCORP Research Base

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Nausea Drug: aprepitant Drug: dexamethasone Drug: granisetron hydrochloride Drug: palonosetron hydrochloride Drug: prochlorperazine Drug: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1021 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Study Start Date : December 2006
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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: dexamethasone
Given orally or IV
Other Name: Decadron
Drug: palonosetron hydrochloride
Given orally or IV
Other Name: Aloxi
Drug: prochlorperazine
Given orally or IV
Other Name: Compazine
Drug: placebo
Given orally
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: dexamethasone
Given orally or IV
Other Name: Decadron
Drug: granisetron hydrochloride
Given orally or IV
Other Name: Kytril
Drug: prochlorperazine
Given orally or IV
Other Name: Compazine
Drug: placebo
Given orally
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: aprepitant
Given orally or IV
Other Name: Emend
Drug: dexamethasone
Given orally or IV
Other Name: Decadron
Drug: palonosetron hydrochloride
Given orally or IV
Other Name: Aloxi
Drug: placebo
Given orally
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: dexamethasone
Given orally or IV
Other Name: Decadron
Drug: palonosetron hydrochloride
Given orally or IV
Other Name: Aloxi
Drug: prochlorperazine
Given orally or IV
Other Name: Compazine
Drug: placebo
Given orally


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475085


Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36695
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
CCOP - North Shore University Hospital
Manhassett, New York, United States, 11030
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Joseph Roscoe
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joseph A. Roscoe, PhD James P. Wilmot Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph Roscoe, Research Associate Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00475085     History of Changes
Other Study ID Numbers: CDR0000544841
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-U1105 ( Other Identifier: University of Rochester )
First Posted: May 17, 2007    Key Record Dates
Results First Posted: November 4, 2013
Last Update Posted: November 10, 2015
Last Verified: October 2015

Keywords provided by Joseph Roscoe, University of Rochester NCORP Research Base:
nausea and vomiting
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
 stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
inflammatory breast cancer
male breast cancer

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Aprepitant
Fosaprepitant
Granisetron
Prochlorperazine
BB 1101
Palonosetron
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents