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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Treatment of Delayed Nausea: What Works Best?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020657
• Other study ID #: CDR0000068694
• Secondary ID: URCC-U3901NCI-P0
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2001
• Last updated: October 13, 2015
• Start date: July 2001
• Est. completion date: October 2004

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• dolasetron mesylate

• granisetron hydrochloride

• ondansetron

• prochlorperazine

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	CCOP - Greenville	Greenville	South Carolina
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Lanc — View Citation