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Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer

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: NCT00020657
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 15, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

Brief Summary:

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy.

PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific Drug: dolasetron mesylate Drug: granisetron hydrochloride Drug: ondansetron Drug: prochlorperazine Procedure: quality-of-life assessment Phase 3

Detailed Description:


  • Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
  • Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
  • Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
  • Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.

Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.

Patients are then randomized to 1 of 3 antiemetic arms.

  • Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.
  • Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.
  • Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3.

Quality of life is assessed at baseline and on day 4.

PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Treatment of Delayed Nausea: What Works Best?
Study Start Date : July 2001
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of cancer for which a chemotherapy regimen containing doxorubicin (with adjuvant, neoadjuvant, curative, or palliative intent) is scheduled
  • Scheduled chemotherapy regimen must not include any of the following:

    • Multiple doses of doxorubicin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin
    • Doxorubicin HydroCloride liposome or cisplatin
  • Scheduled chemotherapy regimen may contain agents, other than those listed above, administered orally, IV, or IV continuously on 1 or multiple days
  • Must be scheduled to receive a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone concurrently with doxorubicin
  • No clinical evidence of an impending bowel obstruction
  • No symptomatic brain metastasis



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy:

  • No concurrent interferon


  • See Disease Characteristics
  • No prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • No concurrent radiotherapy


  • Not specified


  • Concurrent rescue medications (as appropriate) for control of symptoms caused by cancer or its treatment allowed

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): NCT00020657

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United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
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Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
Publications of Results:
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Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00020657    
Other Study ID Numbers: CDR0000068694
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015
Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
nausea and vomiting
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents