APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
NCT ID: NCT00343460
Last Updated: 2017-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1428 participants
INTERVENTIONAL
2006-06-30
2009-02-28
Brief Summary
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Detailed Description
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Primary
* Compare the overall activity and effects of APF530 versus palonosetron hydrochloride in combination with dexamethasone for prophylaxis of acute- or delayed-onset, chemotherapy-induced nausea and vomiting in patients undergoing moderately or highly emetogenic chemotherapy for cancer.
Secondary
* Evaluate the safety, tolerability, and efficacy of APF530, in terms of prevention of acute- and delayed-onset nausea and vomiting, in these patients.
* Gather the pharmacokinetics of APF530 in a subset of patients during chemotherapy course 1.
* Gather ECG data (using 24-hour Holter monitoring) in a subset of patients during chemotherapy course 1.
OUTLINE: This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are stratified according to emetogenicity of scheduled chemotherapy (moderate-risk \[level 3 or 4\] vs high-risk \[level 5\]). Patients are randomized to 1 of 3 treatment arms (I, II, and III). Patients who are randomized to receive palonosetron hydrochloride during chemotherapy course 1 (arm I) are then re-randomized to 1 of 2 treatment arms (II and III) after chemotherapy course 1 to receive treatment during chemotherapy courses 2-4.
Patients receive palonosetron hydrochloride or APF530 and/or placebo 30-60 minutes before the start of chemotherapy. Patients receive dexamethasone 30-90 minutes before the start of chemotherapy.
* Arm I: Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.
* Arm II: Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
* Arm III: Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
A subset of patients undergo blood collection periodically during study for analysis of plasma APF530 concentration.
Quality of life is assessed on day 5 after completion of chemotherapy course 1.
After completion of study treatment, patients are followed at approximately 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I
Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.
dexamethasone
Given IV and orally
Palonosetron Hydrochloride
Given IV
placebo
Given subcutanously or IV
Arm II
Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
APF530
Given subcutanously
dexamethasone
Given IV and orally
placebo
Given subcutanously or IV
Arm III
Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.
APF530
Given subcutanously
dexamethasone
Given IV and orally
placebo
Given subcutanously or IV
Interventions
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APF530
Given subcutanously
dexamethasone
Given IV and orally
Palonosetron Hydrochloride
Given IV
placebo
Given subcutanously or IV
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed malignant disease
* No head and neck cancer or upper gastrointestinal cancer
* Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses)
* Chemotherapy administration ≤ 4 hours
* Duration of each course ≤ 28 days
* Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm
* Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment
* No greater than mild nausea or any vomiting within 24 hours before beginning study treatment
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics
* QTc interval ≤ 500 ms
* No cardiac abnormality predisposing the patient to arrhythmia
* No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation
* No recent history (i.e., ≤ 1 year) of alcohol or drug abuse
* No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment
* More than 7 days since prior chemotherapy
* More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications)
* More than 7 days since prior antinausea medications
* More than 30 days since prior treatment on an investigational trial
* No other concurrent corticosteroids or dexamethasone at a different dose than study treatment
* No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications
18 Years
120 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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John Barr, PhD
Role: STUDY_CHAIR
Heron Therapeutics
Locations
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Anniston Oncology, PC
Anniston, Alabama, United States
Palo Verde Hematology Oncology - Glendale
Glendale, Arizona, United States
Arizona Clinical Research Center, Incorporated
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Incorporated
Anaheim, California, United States
Southbay Oncology / Hematology Medical Group
Campbell, California, United States
Compassionate Cancer Care Medical Group Incorporated - Corona
Corona, California, United States
Compassionate Cancer Care Medical Group Incorporated - Fountain Valley
Fountain Valley, California, United States
Advanced Research Management Services, Incorporated
Los Angeles, California, United States
Kenmar Research Institute
Los Angeles, California, United States
Medical Oncology Care Associates - Orange
Orange, California, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Providence Hospital
Washington D.C., District of Columbia, United States
Pasco Pinellas Cancer Center - New Port Richey
New Port Richey, Florida, United States
Innovative Medical Research of South Florida, Incorporated
North Miami Beach, Florida, United States
Columbus Clinic, PC
Columbus, Georgia, United States
Clintell, Incorporated
Skokie, Illinois, United States
Investigative Clinical Research, LLC
Indianapolis, Indiana, United States
Cancer Center of Indiana
New Albany, Indiana, United States
Family Medicine of Vincennes Clinical Trial Center
Vincennes, Indiana, United States
Medical Center Vincennes
Vincennes, Indiana, United States
Kentucky Cancer Clinic - Hazard
Hazard, Kentucky, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States
Hematology-Medical Oncology Associates at Central Maine Comprehensive Cancer Center
Lewiston, Maine, United States
Mercy Medical Center
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders at Suburban Hospital
Bethesda, Maryland, United States
Center for Clinical Research at Washington County Hospital
Hagerstown, Maryland, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Kansas City Cancer Centers - South
Kansas City, Missouri, United States
Star Hematology & Oncology
Phillipsburg, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Falck Cancer Center at Arnot Ogden Medical Center
Elmira, New York, United States
Hudson Valley Hematology-Oncology Associates - Poughkeepsie
Poughkeepsie, New York, United States
Comprehensive Cancer Center at Pardee Hospital
Hendersonville, North Carolina, United States
Boice Willis Clinic, PA
Rocky Mount, North Carolina, United States
Eastern North Carolina Medical Group, PLLC
Rocky Mount, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Gabrail Cancer Center - Canton Office
Canton, Ohio, United States
Gabrail Cancer Center - Dover Office
Dover, Ohio, United States
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States
Signal Point Hematology Oncology Incorporated
Middletown, Ohio, United States
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Pottsville Cancer Clinic
Pottsville, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
Julie and Ben Rogers Cancer Institute at Memorial Hermann Baptist Beaumont Hospital
Beaumont, Texas, United States
Texas Cancer Clinic
San Antonio, Texas, United States
Cancer Outreach Associates - Abingdon
Abingdon, Virginia, United States
Virginia Oncology Care, PC
Richlands, Virginia, United States
Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center
Lacey, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
Countries
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References
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Boccia R, O'Boyle E, Cooper W. Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy. BMC Cancer. 2016 Feb 26;16:166. doi: 10.1186/s12885-016-2186-4.
Raftopoulos H, Boccia R, Cooper W, O'Boyle E, Gralla RJ. Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. Future Oncol. 2015 Sep;11(18):2541-51. doi: 10.2217/fon.15.185. Epub 2015 Aug 20.
Other Identifiers
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APPA-C2006-01
Identifier Type: -
Identifier Source: secondary_id
C2006-01
Identifier Type: -
Identifier Source: org_study_id
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