Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
- Conditions
- LymphomaUnspecified Childhood Solid Tumor, Protocol SpecificChronic Myeloproliferative DisordersNausea and VomitingPrecancerous ConditionMyelodysplastic SyndromesLeukemiaMultiple Myeloma and Plasma Cell NeoplasmSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: placebo
- Registration Number
- NCT00006348
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: ondansetron + placebo placebo 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. Arm 1: ondansetron + placebo ondansetron 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 1: ondansetron + placebo placebo 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 2: ondansetron + placebo ondansetron 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.
- Primary Outcome Measures
Name Time Method response Up to 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States