 |
Clinical Trial Questions?
|
|
|
Phase III Randomized Study of Different Combinations of Granisetron Hydrochloride, Dexamethasone, Prochlorperazine, Aprepitant, and Palonosetron Hydrochloride in Preventing Delayed Nausea in Patients Undergoing Chemotherapy for Chemotherapy-Naive Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Granisetron, Dexamethasone, Prochlorperazine, Aprepitant, and Palonosetron in Preventing Nausea in Patients Undergoing Chemotherapy for Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Supportive care | Active | 18 and over | URCC-04-02
URCC 0402, URCC-U1105, U1105, NCT00475085 |
Special Category:
NCI Web site featured 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.
Entry 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
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
Patient Characteristics:
- Menopausal status not specified
- No concurrent or impending bowel obstruction
- Able to understand English
Expected Enrollment 890A total of 890 patients will be accrued for this study. Outcomes Primary Outcome(s)Severity of delayed nausea
Interference with functioning caused by nausea or emesis
Secondary Outcome(s)Change in quality of life score between pre- and post-treatment measurements
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.
Trial Contact Information
Trial Lead Organizations University of Rochester Cancer Center CCOP Research Base | | | | Joseph Roscoe, PhD, Principal investigator | | | |
Trial Sites
|
|
|
|
| U.S.A. |
|
| Alabama |
|
| |
Mobile |
|
| | | | | | | | | MBCCOP - Gulf Coast |
| | | Thaddeus Beeker, MD | |
|
| Illinois |
|
| |
Decatur |
|
| | | | CCOP - Central Illinois |
| | | James Wade, MD | |
| | Email:
peggyv@dmhhs.org |
|
| Kansas |
|
| |
Wichita |
|
| | | | CCOP - Wichita |
| | | Shaker Dakhil, MD, FACP | | Ph: | 316-268-5784 | | 800-362-5784 |
|
| | Email:
marge_good@via-christi.org |
|
| Michigan |
|
| |
Grand Rapids |
|
| | | | CCOP - Grand Rapids |
| | | Marianne Lange, MD | |
| | Email:
connie.szczepanek@grcop.org |
|
| |
Kalamazoo |
|
| | | CCOP - Kalamazoo |
| | | Raymond Lord, MD | |
| | Email:
rlord@wmcc.org |
|
| Minnesota |
|
| |
St. Louis Park |
|
| | | | CCOP - Metro-Minnesota |
| | | Patrick Flynn, MD | |
| | Email:
hillre@parknicollet.com |
|
| Missouri |
|
| |
Kansas City |
|
| | | | CCOP - Kansas City |
| | | Rakesh Gaur, MD | |
| | Email:
leslie.herst@hcamidwest.com |
|
| Nevada |
|
| |
Las Vegas |
|
| | | | CCOP - Nevada Cancer Research Foundation |
| | | John Ellerton, MD, CM | |
| | Email:
k.vanwagenen@sncrf.org |
|
| New York |
|
| |
East Syracuse |
|
| | | | CCOP - Hematology-Oncology Associates of Central New York |
| | | Jeffrey Kirshner, MD | |
| | Email:
csweeney@hoacny.com |
|
| |
Manhassett |
|
| | | CCOP - North Shore University Hospital |
| | | Vincent Vinciguerra, MD | |
| | Email:
nnier@nshs.edu |
|
| North Carolina |
|
| |
Goldsboro |
|
| | | | CCOP - Southeast Cancer Control Consortium |
| | | James Atkins, MD | |
| | Email:
rburgess@wfubmc.edu |
|
| Ohio |
|
| |
Columbus |
|
| | | | CCOP - Columbus |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
debby@mail.columbus-ccop.org |
|
| |
Dayton |
|
| | | CCOP - Dayton |
| | | Howard Gross, MD | |
| | Email:
bernadette.bensman@wright.edu |
|
| South Carolina |
|
| |
Greenville |
|
| | | | CCOP - Greenville |
| | | Jeffrey Giguere, MD, FACP | |
| | Email:
lyndon.evans@usoncology.com |
|
| Washington |
|
| |
Tacoma |
|
| | | | CCOP - Northwest |
| | | Lauren Colman, MD | |
| | Email:
karyn.hart@multicare.org |
|
| Wisconsin |
|
| |
Marshfield |
|
| | | | CCOP - Marshfield Clinic Research Foundation |
| | | Tarit Banerjee, MD, FACP | |
| | Email:
banerjee.tarit@marshfieldclinic.org |
|
Related Information Featured trial article
| Registry Information | | | Official Title | | Prevention of Delayed Nausea
A Phase III Double-Blind Placebo-Controlled Clinical Trial | | | Trial Start Date | | 2006-12-13 | | | Trial Completion Date | | 2010-12-31 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00475085 | | | Date Submitted to PDQ | | 2007-04-24 | | | Information Last Verified | | 2009-06-14 | | | NCI Grant/Contract Number | | CA37420 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
