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

NCT00020657 | Completed Phase 3

• 3 other identifiers: CDR0000068694URCC-U3901NCI-P01-0180
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 15

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.

Conditions

Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

nausea and vomiting; unspecified adult solid tumor, protocol specific

Interventions

dolasetron mesylate DRUG

granisetron hydrochloride DRUG

ondansetron DRUG

prochlorperazine DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gary Morrow: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Related 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. Lancet Oncol. 2005 Oct;6(10):765-72. doi: 10.1016/S1470-2045(05)70325-9. Epub 2005 Sep 13.

  PMID: 16198982 RESULT

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

dolasetron; Granisetron; Ondansetron; Prochlorperazine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Phenothiazines; Sulfur Compounds

Study Officials

• Gary R. Morrow, PhD, MS

  James P. Wilmot Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, University of Rochester NCORP Research Base

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

US (15)