Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

NCT00475085 | Completed Phase 3 Results DMC

• 3 other identifiers: CDR0000544841U10CA037420URCC-U1105
• Study Type: interventional
• Target: 1,021
• Locations: 1 country
• Sites: 16

Brief Summary

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy. PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

Conditions

Nausea

Keywords

nausea and vomiting; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; inflammatory breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Home Record: Severity of Delayed Nausea

  1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse

  average of day 1 afternoon, evening and night, and all of days 2 and 3

Study Arms (4)

Arm I

ACTIVE COMPARATOR

Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.

Drug: dexamethasone; Drug: palonosetron hydrochloride; Drug: prochlorperazine; Drug: placebo

Arm II

EXPERIMENTAL

Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.

Drug: dexamethasone; Drug: granisetron hydrochloride; Drug: prochlorperazine; Drug: placebo

Arm III

ACTIVE COMPARATOR

Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.

Drug: aprepitant; Drug: dexamethasone; Drug: palonosetron hydrochloride; Drug: placebo

Arm IV

EXPERIMENTAL

Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Drug: dexamethasone; Drug: palonosetron hydrochloride; Drug: prochlorperazine; Drug: placebo

Interventions

aprepitant DRUG

Given orally or IV

Also known as: Emend

Arm III

dexamethasone DRUG

Given orally or IV

Also known as: Decadron

Arm I; Arm II; Arm III; Arm IV

granisetron hydrochloride DRUG

Given orally or IV

Also known as: Kytril

Arm II

palonosetron hydrochloride DRUG

Given orally or IV

Also known as: Aloxi

Arm I; Arm III; Arm IV

prochlorperazine DRUG

Given orally or IV

Also known as: Compazine

Arm I; Arm II; Arm IV

placebo DRUG

Given orally

Arm I; Arm II; Arm III; Arm IV

Eligibility Criteria

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

You may qualify if:

• Have a diagnosis of cancer and be chemotherapy naive.
• Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment
• Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent.
• Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed.
• For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin.
• Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days.
• Able to understand English

You may not qualify if:

• No symptomatic brain metastases
• No concurrent or impending bowel obstruction
• Regimens containing liposomal doxorubicin or cisplatin are not allowed.
• No concurrent pimozide, terfenadine, astemizole, or cisapride
• No concurrent doxorubicin hydrochloride liposome or cisplatin
• No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin

Sponsors & Collaborators

• Joseph Roscoe: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

MBCCOP - Gulf Coast

Mobile, Alabama, 36695, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

CCOP - North Shore University Hospital

Manhassett, New York, 11030, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, 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

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (1)

• Roscoe JA, Heckler CE, Morrow GR, Mohile SG, Dakhil SR, Wade JL, Kuebler JP. Prevention of delayed nausea: a University of Rochester Cancer Center Community Clinical Oncology Program study of patients receiving chemotherapy. J Clin Oncol. 2012 Sep 20;30(27):3389-95. doi: 10.1200/JCO.2011.39.8123. Epub 2012 Aug 20.

  PMID: 22915657 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting; Breast Neoplasms; Inflammatory Breast Neoplasms; Breast Neoplasms, Male

Interventions

Aprepitant; Dexamethasone; Calcium Dobesilate; Granisetron; Palonosetron; Prochlorperazine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Azabicyclo Compounds; Aza Compounds; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinuclidines; Isoquinolines; Phenothiazines; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dr. Charles Heckler
• Organization: University of Rochester

checkler@urmc.rochester.edu

585 273-1141

Study Officials

• Joseph A. Roscoe, PhD

  James P. Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: December 1, 2006
• Primary Completion: December 1, 2012
• Last Updated: November 10, 2015
• Results First Posted: November 4, 2013

Record last verified: 2015-10

Locations

US (16)