Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| 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 | Drug: ondansetron Other: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Supportive Care |
| 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 |
- response [ Time Frame: Up to 12 months ]
| Enrollment: | 100 |
| Study Start Date: | October 2000 |
| Study Completion Date: | September 2001 |
| Primary Completion Date: | September 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1: ondansetron + 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.
|
Drug: ondansetron Other: placebo |
|
Experimental: Arm 2: ondansetron + 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.
|
Drug: ondansetron Other: placebo |
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.
Eligibility
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006348
| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, North Dakota | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501 | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
More Information
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00006348 History of Changes |
| Other Study ID Numbers: |
NCCTG-989201 CDR0000068205 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-P00-0168 |
| First Submitted: | October 4, 2000 |
| First Posted: | March 25, 2004 |
| Last Update Posted: | July 6, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Alliance for Clinical Trials in Oncology:
|
stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenström macroglobulinemia stage III multiple myeloma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia |
recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma unspecified childhood solid tumor, protocol specific unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies untreated childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Lymphoma Syndrome Leukemia Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Nausea Vomiting Plasmacytoma Myeloproliferative Disorders Precancerous Conditions Intestinal Neoplasms Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Signs and Symptoms, Digestive |