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

• ClinicalTrials.gov Identifier: NCT00020657
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: October 15, 2015
• Sponsor: Gary Morrow
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Gary Morrow, University of Rochester NCORP Research Base

Tracking Information

• First Submitted Date: July 11, 2001
• First Posted Date: January 27, 2003
• Last Update Posted Date: October 15, 2015
• Study Start Date: July 2001
• Actual Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
• Official Title: Treatment of Delayed Nausea: What Works Best?

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.

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Primary Purpose: Supportive Care

Condition

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

Intervention

• Drug: dolasetron mesylate
• Drug: granisetron hydrochloride
• Drug: ondansetron
• Drug: prochlorperazine
• Procedure: quality-of-life assessment

• Study Arms: Not Provided
• Publications *: 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. doi: 10.1016/S1470-2045(05)70325-9. Epub 2005 Sep 13.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 2004
• Actual Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)

Eligibility 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, 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00020657
• Other Study ID Numbers: CDR0000068694; URCC-U3901; NCI-P01-0180
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gary Morrow, University of Rochester NCORP Research Base
• Original Responsible Party: Not Provided
• Current Study Sponsor: Gary Morrow
• Original Study Sponsor: James P. Wilmot Cancer Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Gary R. Morrow, PhD, MS; James P. Wilmot Cancer Center

• PRS Account: University of Rochester
• Verification Date: October 2015