Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: dolasetron mesylate (Drug); granisetron hydrochloride (Drug); ondansetron (Drug); prochlorperazine (Drug); quality-of-life assessment (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: James P. Wilmot Cancer Center Official(s) and/or principal investigator(s):
Gary R. Morrow, PhD, MS, Study Chair, Affiliation: James P. Wilmot Cancer Center
Summary
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.
Clinical Details
Official title: Treatment of Delayed Nausea: What Works Best?
Study design: Supportive Care, Randomized, Active Control
Detailed description:
OBJECTIVES:
- 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- 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, hexamethylamine, nitrosoureas, or
streptozocin
- Doxorubicin HCl 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
Locations and Contacts
MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States
MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States
CCOP - North Shore University Hospital, Manhasset, New York 11030, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States
CCOP - Columbus, Columbus, Ohio 43206, United States
CCOP - Dayton, Dayton, Ohio 45429, United States
CCOP - Greenville, Greenville, South Carolina 29615, United States
CCOP - Northwest, Tacoma, Washington 98405-0986, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2001
Last updated: May 23, 2008
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