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

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: dolasetron mesylate (Drug); granisetron hydrochloride (Drug); ondansetron (Drug); prochlorperazine (Drug); quality-of-life assessment (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: James P. Wilmot Cancer Center

Official(s) and/or principal investigator(s):
Gary R. Morrow, PhD, MS, Study Chair, Affiliation: James P. Wilmot Cancer Center

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.

Clinical Details

Official title: Treatment of Delayed Nausea: What Works Best?

Study design: Supportive Care, Randomized, Active Control

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States

CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2001
Last updated: May 23, 2008

Page last updated: June 20, 2008

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