Treatment of Delayed Nausea: What Works Best?
18 Years
N/A
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Treatment of Delayed Nausea: What Works Best?
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.
Inclusion 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, 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
Gary R. Morrow, PhD, MS
Investigator Role:
Study Chair
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068694
NCT ID:
NCT00020657
Start Date:
July 2001
Completion Date:
October 2004
Related Keywords:
- Nausea and Vomiting
- Unspecified Adult Solid Tumor, Protocol Specific
- nausea and vomiting
- unspecified adult solid tumor, protocol specific
- Nausea
- Vomiting
Name | Location |
|---|---|
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
