Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
NCT ID: NCT00903396
Last Updated: 2017-11-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2009-09-30
2013-05-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.
Detailed Description
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* Evaluate the rate of complete responses, defined as no vomiting and no nausea, in patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy as part of their cancer treatment.
* Determine the tolerability of palonosetron hydrochloride vs placebo in these patients.
* Validate patient diaries for assessing nausea and vomiting by comparing with alternative methods for measuring nausea and vomiting in order to determine the optimal approach for future studies.
OUTLINE: Patients are stratified according to planned radiotherapy duration (\< 5 weeks vs ≥ 5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients receive palonosetron hydrochloride IV on day 1.
* Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4.
* Arm III: Patients receive placebo IV on day 1.
* Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly during radiotherapy in the absence of disease progression or unacceptable toxicity.
Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.
Conditions
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Keywords
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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 on day 1.
palonosetron hydrochloride
Given IV
Arm II
Patients receive palonosetron hydrochloride IV on days 1 and 4.
palonosetron hydrochloride
Given IV
Arm III
Patients receive placebo IV on day 1.
placebo
Given IV
Arm IV
Patients receive placebo IV on days 1 and 4.
placebo
Given IV
Interventions
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palonosetron hydrochloride
Given IV
placebo
Given IV
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma
* Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen
* Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm\^2
* No brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to complete questionnaire(s) alone or with assistance
* Willing to return to NCCTG enrolling institution for follow-up
* Able to reliably take oral medication (for purposes of rescue medication)
* No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists
* No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* No nausea ≤ 48 hours prior to study enrollment
* No history of dystonic reactions to prochlorperazine or haloperidol or related agents
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 7 days since prior agents known to have significant effects on emesis, including the following:
* Ondansetron
* Sedating antihistamines
* Antipsychotics
* Cannabinoids
* Corticosteroids
* Metoclopramide
* Narcotic analgesics
* Benzodiazepines
* More than 7 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer
* More than 7 days since of prior cetuximab
* More than 7 days since prior and no concurrent oral steroids
* No prior palonosetron hydrochloride
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Michele Yvette Halyard, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States
Moline, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Bettendorf, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Wesley Medical Center
Wichita, Kansas, United States
Michiana Hematology Oncology PC - Niles
Niles, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Fergus Falls Medical Group, PA
Fergus Falls, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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NCI-2009-01109
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000642449
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N08C2
Identifier Type: -
Identifier Source: org_study_id