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Sponsors and Collaborators: |
University of Rochester National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00475085 |
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 women undergoing chemotherapy for breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Nausea and Vomiting |
Drug: aprepitant Drug: dexamethasone Drug: granisetron hydrochloride Drug: palonosetron hydrochloride Drug: placebo Drug: prochlorperazine |
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 |
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 |
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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.
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Drug: dexamethasone
Given orally or IV
Drug: palonosetron hydrochloride
Given orally or IV
Drug: placebo
Given orally
Drug: prochlorperazine
Given orally or IV
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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.
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Drug: dexamethasone
Given orally or IV
Drug: granisetron hydrochloride
Given orally or IV
Drug: placebo
Given orally
Drug: prochlorperazine
Given orally or IV
|
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.
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Drug: aprepitant
Given orally or IV
Drug: dexamethasone
Given orally or IV
Drug: palonosetron hydrochloride
Given orally or IV
Drug: placebo
Given orally
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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: placebo
Given orally
Drug: prochlorperazine
Given orally or IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride or epirubicin hydrochloride (any dose or schedule) without concurrent radiotherapy or interferon treatment
Dose-dense regimens allowed (e.g., doxorubicin hydrochloride or epirubicin hydrochloride given every 2 weeks)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, or streptozocin
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 |
Principal Investigator: | Joseph A. Roscoe, PhD | James P. Wilmot Cancer Center |
Study ID Numbers: | CDR0000544841, URCC-04-02, URCC-U1105 |
Study First Received: | May 16, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00475085 |
Health Authority: | Unspecified |
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 |
Dexamethasone Prochlorperazine Vomiting Skin Diseases Signs and Symptoms, Digestive Breast Neoplasms Serotonin Recurrence Signs and Symptoms |
Palonosetron Inflammatory breast cancer Dopamine Nausea Granisetron Breast Diseases Dexamethasone acetate Aprepitant |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Antiemetics Hormones Serotonin Antagonists Neoplasms by Site Therapeutic Uses Tranquilizing Agents |
Antineoplastic Agents, Hormonal Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Glucocorticoids Pharmacologic Actions Neoplasms Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |