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| Sponsors and Collaborators: |
James P. Wilmot Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020657 |
Purpose
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.
| Condition | Intervention | Phase |
|
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 III |
| MedlinePlus related topics: | Cancer Nausea and Vomiting |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| Official Title: | Treatment of Delayed Nausea: What Works Best? |
| Study Start Date: | July 2001 |
OBJECTIVES:
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.
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Scheduled chemotherapy regimen must not include any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Alabama | |||||
| MBCCOP - Gulf Coast | |||||
| Mobile, Alabama, United States, 36688 | |||||
| United States, Arizona | |||||
| CCOP - Mayo Clinic Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| CCOP - Western Regional, Arizona | |||||
| Phoenix, Arizona, United States, 85006-2726 | |||||
| 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 | |||||
| James P. Wilmot Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Gary R. Morrow, PhD, MS | James P. Wilmot Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068694, URCC-U3901, NCI-P01-0180 |
| First Received: | July 11, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00020657 |
| Health Authority: | United States: Federal Government |
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