Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Nausea and Vomiting; Precancerous Condition; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific
Intervention: ondansetron (Drug); placebo (Other)
Phase: Phase 3
Sponsored by: Alliance for Clinical Trials in Oncology
Official(s) and/or principal investigator(s):
Steven R. Alberts, MD, Study Chair, Affiliation: Mayo Clinic
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.
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: response
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.
Minimum age: N/A.
Maximum age: N/A.
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
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
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
Locations and Contacts
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States
Medcenter One Health System, Bismarck, North Dakota 58501, United States
Altru Health Systems, Grand Forks, North Dakota 58201, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2000
Last updated: July 14, 2015