Granisetron, Dexamethasone, Prochlorperazine, Aprepitant, and Palonosetron in Preventing Nausea in Patients Undergoing Chemotherapy for Breast Cancer - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00475085

Purpose

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	Intervention	Phase
Breast Cancer Nausea and Vomiting	Drug: aprepitant Drug: dexamethasone Drug: granisetron hydrochloride Drug: palonosetron hydrochloride Drug: prochlorperazine Other: placebo	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Severity of delayed nausea [ Designated as safety issue: No ]
Interference with functioning caused by nausea or emesis [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in quality of life score between pre- and post-treatment measurements [ Designated as safety issue: No ]

Estimated Enrollment:	890
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator 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 Drug: palonosetron hydrochloride Given orally or IV Drug: prochlorperazine Given orally or IV Other: placebo Given orally
Arm II: Experimental 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 Drug: granisetron hydrochloride Given orally or IV Drug: prochlorperazine Given orally or IV Other: placebo Given orally
Arm III: Active Comparator 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 Drug: dexamethasone Given orally or IV Drug: palonosetron hydrochloride Given orally or IV Other: placebo Given orally
Arm IV: Experimental 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 Drug: palonosetron hydrochloride Given orally or IV Drug: prochlorperazine Given orally or IV Other: placebo Given orally

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)
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475085

Locations

United States, Alabama
MBCCOP - Gulf Coast	Recruiting
Mobile, Alabama, United States, 36695
Contact: Thaddeus A. Beeker, MD 251-631-3542
United States, Illinois
CCOP - Central Illinois	Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade, MD 217-876-6618 peggyv@dmhhs.org
United States, Kansas
CCOP - Wichita	Recruiting
Wichita, Kansas, United States, 67214-3882
Contact: Shaker R. Dakhil, MD, FACP 316-268-5784 marge_good@via-christi.org
United States, Michigan
CCOP - Grand Rapids	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Marianne K. Lange, MD 616-391-1230 connie.szczepanek@grcop.org
CCOP - Kalamazoo	Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Raymond S. Lord, MD 269-373-7458 rlord@wmcc.org
United States, Minnesota
CCOP - Metro-Minnesota	Recruiting
St. Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD 952-993-1576 hillre@parknicollet.com
United States, Missouri
CCOP - Kansas City	Recruiting
Kansas City, Missouri, United States, 64131
Contact: Rakesh Gaur, MD 816-823-0555 leslie.herst@hcamidwest.com
United States, Nevada
CCOP - Nevada Cancer Research Foundation	Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
United States, New York
CCOP - Hematology-Oncology Associates of Central New York	Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD 315-472-7504 csweeney@hoacny.com
CCOP - North Shore University Hospital	Recruiting
Manhassett, New York, United States, 11030
Contact: Vincent P. Vinciguerra, MD 516-734-8918 nnier@nshs.edu
United States, North Carolina
CCOP - Southeast Cancer Control Consortium	Recruiting
Goldsboro, North Carolina, United States, 27534-9479
Contact: James N. Atkins, MD 336-777-3036 rburgess@wfubmc.edu
United States, Ohio
CCOP - Columbus	Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD 614-488-2647 debby@mail.columbus-ccop.org
CCOP - Dayton	Recruiting
Dayton, Ohio, United States, 45429
Contact: Howard M. Gross, MD 937-395-8679 bernadette.bensman@wright.edu
United States, South Carolina
CCOP - Greenville	Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere, MD, FACP 864-241-6251 lyndon.evans@usoncology.com
United States, Washington
CCOP - Northwest	Recruiting
Tacoma, Washington, United States, 98405-0986
Contact: Lauren K. Colman, MD 253-403-1461 karyn.hart@multicare.org
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation	Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Tarit K. Banerjee, MD, FACP 715-389-5592 banerjee.tarit@marshfieldclinic.org

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Joseph A. Roscoe, PhD

James P. Wilmot Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	James P. Wilmot Cancer Center at University of Rochester Medical Center ( Gary R. Morrow )
Study ID Numbers:	CDR0000544841, URCC-04-02, URCC-U1105
Study First Received:	May 16, 2007
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00475085 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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:

Anti-Inflammatory Agents
Dexamethasone
Prochlorperazine
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Signs and Symptoms
Serotonin Antagonists

Neoplasms by Site
Therapeutic Uses
Nausea
Breast Diseases
Dexamethasone acetate
Aprepitant
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Skin Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Breast Neoplasms
Dopamine Antagonists
Antipsychotic Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 27, 2009