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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00006348

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Locations

Arms

Duration (Months)

8.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Oct 1, 2000

Actual Primary Completion Date :

Sep 1, 2001

Actual Study Completion Date :

Sep 1, 2001

Arms and Interventions

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

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

Primary Outcome Measures

response [Up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
3	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
4	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
5	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
6	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
7	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
8	Medcenter One Health System	Bismarck	North Dakota	United States	58501
9	Altru Health Systems	Grand Forks	North Dakota	United States	58201
10	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
11	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
12	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080