Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
NCT00903396 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2017-11-24
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.
Conditions
- Anal Cancer
- Carcinoma of the Appendix
- Colorectal Cancer
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- Gastric Cancer
- Gastrointestinal Carcinoid Tumor
- Liver Cancer
- Nausea and Vomiting
- Pancreatic Cancer
- Primary Peritoneal Cavity Cancer
- Small Intestine Cancer
Interventions
- DRUG
-
palonosetron hydrochloride
Given IV
- OTHER
-
placebo
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Michele Yvette Halyard, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2011-01-31
- Completion
- 2013-05-31
Countries
- United States
Study Locations
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