A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Complete response (no episodes of nausea or vomiting)
No
Michele Yvette Halyard, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000642449
NCT00903396
September 2009
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Hinsdale, Illinois 60521 | |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Wesley Medical Center | Wichita, Kansas 67214 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
South Bend Clinic | South Bend, Indiana 46617 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Bettendorf, Iowa 52722 | |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
Michiana Hematology Oncology PC - Niles | Niles, Michigan 49120 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Fergus Falls Medical Group, PA | Fergus Falls, Minnesota 56537 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
Franciscan Skemp Healthcare - La Crosse Campus | La Crosse, Wisconsin 54601 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay, Wisconsin 54235-1495 |