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

Last updated: October 13, 2015
Sponsor: Joseph Roscoe
Overall Status: Completed

Phase

3

Condition

Colic

Lactose Intolerance

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT00475085
CDR0000544841
U10CA037420
URCC-U1105
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Have a diagnosis of cancer and be chemotherapy naive.

  • Must be scheduled to receive a chemotherapy treatment containing doxorubicinhydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (anydose 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 twoweeks)are allowed.

  • For the purposes of this study, Day 1 of chemotherapy will be defined as the day ofadministration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.

  • Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin,oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are notallowed. 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

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 Design

Total Participants: 1021
Study Start date:
December 01, 2006
Estimated Completion Date:

Study 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.

Connect with a study center

  • MBCCOP - Gulf Coast

    Mobile, Alabama 36695
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • CCOP - Grand Rapids

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • CCOP - Kalamazoo

    Kalamazoo, Michigan 49007-3731
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York 13057
    United States

    Site Not Available

  • CCOP - North Shore University Hospital

    Manhassett, New York 11030
    United States

    Site Not Available

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina 27534-9479
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43215
    United States

    Site Not Available

  • CCOP - Dayton

    Dayton, Ohio 45429
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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