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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006348
Recruitment Status : Completed
First Posted : March 25, 2004
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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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.


Condition or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : October 2000
Actual Primary Completion Date : September 2001
Actual Study Completion Date : September 2001

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Lymphosarcoma Mantle Cell Lymphoma Myelodysplastic Syndromes Primary Myelofibrosis Chronic Myeloproliferative Disorders Polycythemia Vera Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Lymphocytic Leukemia B-cell Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Cutaneous T-cell Lymphoma Follicular Lymphoma Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Diffuse Large B-Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Monoclonal Gammopathy of Undetermined Significance Mycosis Fungoides Childhood Acute Lymphoblastic Leukemia Primary Central Nervous System Lymphoma Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Essential Thrombocythemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma AL Amyloidosis Small Intestine Cancer Burkitt Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. response [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Steven R. Alberts, MD Mayo Clinic
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00006348    
Other Study ID Numbers: NCCTG-989201
CDR0000068205 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-P00-0168
First Posted: March 25, 2004    Key Record Dates
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:
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Lymphoma
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Precancerous Conditions
Intestinal Neoplasms
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Nausea
Vomiting
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
Gastrointestinal Neoplasms