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Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
This study has been completed.
Study NCT00020657   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
July 2001
 
 
 
Complete list of historical versions of study NCT00020657 on ClinicalTrials.gov Archive Site
 
 
 
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Treatment of Delayed Nausea: What Works Best?

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.

OBJECTIVES:

  • 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.

Phase III
Interventional
Supportive Care, Randomized, Active Control
  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: dolasetron mesylate
  • Drug: granisetron hydrochloride
  • Drug: ondansetron
  • Drug: prochlorperazine
  • Procedure: quality-of-life assessment
 
Hickok JT, Roscoe JA, Morrow GR, Bole CW, Zhao H, Hoelzer KL, Dakhil SR, Moore T, Fitch TR. 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol. 2005 Oct;6(10):765-72. Epub 2005 Sep 13.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • 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, hexamethylamine, nitrosoureas, or streptozocin
    • Doxorubicin HCl 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent interferon

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Concurrent rescue medications (as appropriate) for control of symptoms caused by cancer or its treatment allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020657
 
CDR0000068694, URCC-U3901, NCI-P01-0180
James P. Wilmot Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary R. Morrow, PhD, MS James P. Wilmot Cancer Center
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP