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Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
This study has been completed.
Sponsor:
Joseph Roscoe
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00475085
First received: May 16, 2007
Last updated: October 13, 2015
Last verified: October 2015
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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 |
|---|---|---|
| Nausea | Drug: aprepitant Drug: dexamethasone Drug: granisetron hydrochloride Drug: palonosetron hydrochloride Drug: prochlorperazine Drug: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Nausea and Vomiting
Genetic and Rare Diseases Information Center resources:
Inflammatory Breast Cancer
Breast Cancer, Male
U.S. FDA Resources
Further study details as provided by Joseph Roscoe, University of Rochester NCORP Research Base:
Primary Outcome Measures:
- 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
| Enrollment: | 1021 |
| Study Start Date: | December 2006 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475085
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 ( US NIH Grant/Contract Award Number ) URCC-U1105 ( Other Identifier: University of Rochester ) |
| Study First Received: | May 16, 2007 |
| Results First Received: | July 12, 2013 |
| Last Updated: | October 13, 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 Granisetron Aprepitant Fosaprepitant Prochlorperazine Dexamethasone 21-phosphate 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 Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Neurokinin-1 Receptor Antagonists |
ClinicalTrials.gov processed this record on June 23, 2017