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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Nausea and Vomiting

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Trial Information

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


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)

- Correlate sleep quality, physical exercise, and fatigue with chemotherapy-induced
nausea in these patients.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer

- Chemotherapy-naive disease

- 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 allowed (e.g., doxorubicin hydrochloride or epirubicin
hydrochloride given every 2 weeks)

- No multiple-day doses of doxorubicin hydrochloride or epirubicin
hydrochloride

- No symptomatic brain metastases

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- No concurrent or impending bowel obstruction

- Able to understand English

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- 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

- Multiple-day doses of other chemotherapy agents allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Severity of delayed nausea

Outcome Time Frame:

4 days

Safety Issue:

No

Principal Investigator

Joseph A. Roscoe, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000544841

NCT ID:

NCT00475085

Start Date:

December 2006

Completion Date:

March 2012

Related Keywords:

  • Breast Cancer
  • Nausea and Vomiting
  • 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
  • Breast Neoplasms
  • Nausea
  • Vomiting

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306