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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00006348
First received: October 4, 2000
Last updated: July 1, 2016
Last verified: July 2016
  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 Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • response [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006348

Locations
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
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  NCI-P00-0168 
Study First Received: October 4, 2000
Last Updated: July 1, 2016
Health Authority: United States: Federal Government

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
Leukemia
Syndrome
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Nausea
Vomiting
Plasmacytoma
Myeloproliferative Disorders
Intestinal Neoplasms
Precancerous Conditions
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

ClinicalTrials.gov processed this record on August 25, 2016