Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:October 2000
End Date:September 2001

Use our guide to learn which trials are right for you!

Phase III, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Ondansetron in the Control of Chronic Nausea and Vomiting Not Due to Antineoplastic Therapy in Patients With Advanced Cancer

RATIONALE: Antiemetic drugs, such as ondansetron, may help to reduce or prevent nausea and
vomiting in patients with advanced cancer.

PURPOSE: This randomized phase III trial is studying how well ondansetron works compared to
a placebo in treating patients with advanced cancer and chronic nausea and vomiting that is
not caused by cancer therapy.

OBJECTIVES: I. Compare the antiemetic effect of ondansetron vs placebo in patients with
advanced cancer who suffer from chronic nausea and emesis that is not due to antineoplastic
therapy (i.e., chemotherapy, radiotherapy, immunotherapy, biologic therapy). II. Determine
the toxicity of ondansetron in these patients. III. Evaluate the use of other concurrent
antiemetics in these patients when treated with this regimen.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to abdominal carcinomatosis (yes vs no), renal insufficiency
(creatinine less than 2.0 mg/dL vs creatinine at least 2.0 mg/dL), type of cancer (brain vs
gastrointestinal vs other), and narcotic use (yes vs no). Patients are randomized to one of
two treatment arms. Arm I: Patients receive oral ondansetron twice daily on days 1-7 and
oral placebo twice daily on days 8-14 in the absence of unacceptable toxicity. Arm II:
Patients receive oral placebo twice daily on days 1-7 and oral ondansetron twice daily on
days 8-14 in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study
within 1 year.

DISEASE CHARACTERISTICS: Diagnosis of incurable cancer with chronic nausea and vomiting
lasting at least 1 week that is not due to antineoplastic therapy (i.e., chemotherapy,
radiotherapy, immunotherapy, biologic therapy) Nausea not adequately controlled by
standard antiemetics

PATIENT CHARACTERISTICS: Cardiovascular: No uncontrolled hypertension Other: Not pregnant
or nursing Able to take oral medication (feeding tube allowed) Able to swallow own saliva
No prior phenylketonuria No known allergy or intolerance to 5-HT3 receptor antagonists No
bowel obstruction

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics At least 2 weeks since prior cytotoxic systemic therapy No
concurrent cytotoxic systemic therapy Endocrine therapy: Not specified Radiotherapy: See
Disease Characteristics At least 2 weeks since prior radiotherapy to gastrointestinal
tract No concurrent radiotherapy to gastrointestinal tract Surgery: Not specified Other:
At least 2 weeks since prior 5-HT3 receptor antagonists (i.e., dolasetron, granisetron, or
ondansetron) No other concurrent 5-HT3 receptor antagonists Other concurrent antiemetics
allowed
We found this trial at
12
sites
Sioux City, Iowa 51101
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
Bismarck, North Dakota 58501
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Grand Forks, North Dakota 58201
?
mi
from
Grand Forks, ND
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Scottsdale, Arizona 85259
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Sioux Falls, South Dakota 57104
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials