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

Sponsor

Gary Morrow (Other)

Overall Status

Completed

CT.gov ID

NCT00020657

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Supportive Care

Official Title:

Treatment of Delayed Nausea: What Works Best?

Study Start Date :

Jul 1, 2001

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
2	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
3	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
4	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224
5	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
6	CCOP - Central Illinois	Decatur	Illinois	United States	62526
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
9	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
10	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
11	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
12	CCOP - Columbus	Columbus	Ohio	United States	43206
13	CCOP - Dayton	Dayton	Ohio	United States	45429
14	CCOP - Greenville	Greenville	South Carolina	United States	29615
15	CCOP - Northwest	Tacoma	Washington	United States	98405-0986