Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy.
PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
|Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific||Drug: dolasetron mesylate Drug: granisetron hydrochloride Drug: ondansetron Drug: prochlorperazine Procedure: quality-of-life assessment||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Treatment of Delayed Nausea: What Works Best?|
|Study Start Date:||July 2001|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
- Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
- Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
- Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
- Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.
Patients are then randomized to 1 of 3 antiemetic arms.
- Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.
- Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.
- Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3.
Quality of life is assessed at baseline and on day 4.
PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020657
|United States, Alabama|
|MBCCOP - Gulf Coast|
|Mobile, Alabama, United States, 36688|
|United States, Arizona|
|CCOP - Western Regional, Arizona|
|Phoenix, Arizona, United States, 85006-2726|
|CCOP - Mayo Clinic Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Colorado|
|CCOP - Colorado Cancer Research Program, Incorporated|
|Denver, Colorado, United States, 80224|
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|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 - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, New Jersey|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|CCOP - North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Winston-Salem, North Carolina, United States, 27104-4241|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43206|
|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|
|Study Chair:||Gary R. Morrow, PhD, MS||James P. Wilmot Cancer Center|