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
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Both
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
Both
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
Trial Information
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
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.
Inclusion 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: Age: Not specified Performance status: Not specified Life
expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Not specified Renal:
Not specified 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Steven R. Alberts, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000068205
NCT ID:
NCT00006348
Start Date:
October 2000
Completion Date:
Related Keywords:
- 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
- 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
- polycythemia vera
- primary myelofibrosis
- essential thrombocythemia
- untreated hairy cell leukemia
- progressive hairy cell leukemia, initial treatment
- refractory hairy cell leukemia
- stage IV childhood Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- chronic myelomonocytic leukemia
- T-cell large granular lymphocyte leukemia
- acute undifferentiated leukemia
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- secondary acute myeloid leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- primary central nervous system non-Hodgkin lymphoma
- nausea and vomiting
- prolymphocytic leukemia
- AIDS-related peripheral/systemic lymphoma
- AIDS-related primary CNS lymphoma
- primary systemic amyloidosis
- intraocular lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- childhood myelodysplastic syndromes
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Nausea
- Vomiting
- Precancerous Conditions
- Lymphoma, Large-Cell, Immunoblastic
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| Altru Health Systems | Grand Forks, North Dakota 58201 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
