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Home > "O" Clinical Trials Conditions > Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment  Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
For Condition: Eye Cancer,Lymphoma,Leukemia,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Antiemetic drugs, such as ondansetron, may help to reduce or prevent nausea and vomiting in patients with advanced cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of ondansetron in treating patients who have advanced cancer and chronic nausea and vomiting that is not caused by cancer therapy.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --Patient Characteristics-- - Age: Not specified - Performance status: Not specified - Life expectancy: At least 6 weeks - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, North Central Cancer Treatment Group
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Additional Information:
Study ID Numbers: CDR0000068205; NCCTG-989201,NCI-P00-0168
Study Start Date: October 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006348
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2. Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
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4. Pyroxamide in Treating Patients With Advanced Cancer
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Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
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