Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
- Conditions
- Anal CancerCarcinoma of the AppendixColorectal CancerExtrahepatic Bile Duct CancerGallbladder CancerGastric CancerGastrointestinal Carcinoid TumorLiver CancerNausea and VomitingPancreatic Cancer
- Interventions
- Other: placebo
- Registration Number
- NCT00903396
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting.
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
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I palonosetron hydrochloride Patients receive palonosetron hydrochloride IV on day 1. Arm II palonosetron hydrochloride Patients receive palonosetron hydrochloride IV on days 1 and 4. Arm III placebo Patients receive placebo IV on day 1. Arm IV placebo Patients receive placebo IV on days 1 and 4.
- Primary Outcome Measures
Name Time Method Complete Response (no Episodes of Nausea or Vomiting) Up to 2 years
- Secondary Outcome Measures
Name Time Method Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm Up to 2 years Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day Up to 2 years Proportion of Patients Reporting Treatment Failure Up to 2 years Tolerability and Adverse Events as Assessed by NCI CTC v 3.0 Up to 2 years
Trial Locations
- Locations (67)
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, 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
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Michiana Hematology-Oncology, PC - South Bend
🇺🇸Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸Mishawaka, Indiana, United States
Lakeside Cancer Specialists, PLLC
🇺🇸Saint Joseph, Michigan, United States
Elkhart Clinic, LLC
🇺🇸Elkhart, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
🇺🇸Plymouth, Indiana, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Michiana Hematology Oncology PC - La Porte
🇺🇸Westville, Indiana, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
Fergus Falls Medical Group, PA
🇺🇸Fergus Falls, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, 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 - Elkhart
🇺🇸Elkhart, Indiana, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Michiana Hematology Oncology PC - Niles
🇺🇸Niles, Michigan, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center
🇺🇸Manitowoc, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Door County Cancer Center at Door County Memorial Hospital
🇺🇸Sturgeon Bay, Wisconsin, United States