Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

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.

Entry 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

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

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

Expected Enrollment

A total of 100 patients (50 per arm) will be accrued for this study within 1 
year.

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-4918

Registry Information
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
Trial Start Date		2000-10-20
Trial Completion Date		2001-09-28
Registered in ClinicalTrials.gov		NCT00006348
Date Submitted to PDQ		2000-08-04
Information Last Verified		2008-05-28
NCI Grant/Contract Number		CA31946

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