Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed 18 and over NCI URCC-U3901 NCI-P01-0180, NCT00020657

Objectives

1. 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.
2. Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
3. Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
4. Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

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

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.

Hickok JT, Roscoe JA, Morrow GR, et al.: 5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol 6 (10): 765-72, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Gary Morrow, PhD, MS, Protocol chair		Ph: 585-275-5513

Registry Information
Official Title		Treatment of Delayed Nausea: What Works Best?
Trial Start Date		2001-07-13
Registered in ClinicalTrials.gov		NCT00020657
Date Submitted to PDQ		2001-05-01
Information Last Verified		2004-07-16