Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

Colorectal Cancer Clinical Trial

Official title: A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Appendiceal Neoplasms
• Bile Duct Neoplasms
• Carcinoid Tumor
• Carcinoma of the Appendix
• Cholangiocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Intestinal Neoplasms
• Liver Cancer
• Liver Neoplasms
• Malignant Carcinoid Syndrome
• Nausea
• Nausea and Vomiting
• Neuroendocrine Tumors
• Pancreatic Cancer
• Pancreatic Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer
• Small Intestine Cancer
• Stomach Neoplasms
• Vomiting

• NCT number: NCT00903396
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Terminated
• Phase: Phase 2
• Start date: September 2009
• Completion date: May 2013