Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
NCT ID: NCT00020657
Last Updated: 2015-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2001-07-31
2004-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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dolasetron mesylate
granisetron hydrochloride
ondansetron
prochlorperazine
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cancer for which a chemotherapy regimen containing doxorubicin (with adjuvant, neoadjuvant, curative, or palliative intent) is scheduled
* Scheduled chemotherapy regimen must not include any of the following:
* Multiple doses of doxorubicin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin
* Doxorubicin HydroCloride liposome or cisplatin
* Scheduled chemotherapy regimen may contain agents, other than those listed above, administered orally, IV, or IV continuously on 1 or multiple days
* Must be scheduled to receive a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone concurrently with doxorubicin
* No clinical evidence of an impending bowel obstruction
* No symptomatic brain metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent interferon
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* Concurrent rescue medications (as appropriate) for control of symptoms caused by cancer or its treatment allowed
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director, University of Rochester NCORP Research Base
Principal Investigators
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Gary R. Morrow, PhD, MS
Role: STUDY_CHAIR
James P. Wilmot Cancer Center
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Northwest
Tacoma, Washington, United States
Countries
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References
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Hickok JT, Roscoe JA, Morrow GR, Bole CW, Zhao H, Hoelzer KL, Dakhil SR, Moore T, Fitch TR. 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol. 2005 Oct;6(10):765-72. doi: 10.1016/S1470-2045(05)70325-9. Epub 2005 Sep 13.
Other Identifiers
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URCC-U3901
Identifier Type: -
Identifier Source: secondary_id
NCI-P01-0180
Identifier Type: -
Identifier Source: secondary_id
CDR0000068694
Identifier Type: -
Identifier Source: org_study_id
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