Palonosetron Hydrochloride In Preventing Nausea And Vomiting Caused By Radiation Therapy In Patients With Primary Abdominal Cancer

Study Overview

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

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.

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.

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

DRUG: palonosetron hydrochloride
OTHER: placebo

NCCTG-N08C2
NCI-2009-01109 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trials Reporting System))
CDR0000642449 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-15	Results First Submitted 2016-12-07	Last Update Submitted that met QC Criteria 2017-10-20
First Submitted that Met QC Criteria 2009-05-15	Results First Submitted that Met QC Criteria 2016-12-07	Last Update Posted (ACTUAL) 2017-11-24
First Posted (ACTUAL) 2009-05-18	Results First Posted 2017-02-01	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I Patients receive palonosetron hydrochloride IV on day 1.	DRUG: palonosetron hydrochloride Given IV OTHER: placebo Given IV
EXPERIMENTAL: Arm II Patients receive palonosetron hydrochloride IV on days 1 and 4.	DRUG: palonosetron hydrochloride Given IV OTHER: placebo Given IV
PLACEBO_COMPARATOR: Arm III Patients receive placebo IV on day 1.	OTHER: placebo Given IV
PLACEBO_COMPARATOR: Arm IV Patients receive placebo IV on days 1 and 4.	OTHER: placebo Given IV

Primary Outcome Measures	Measure Description	Time Frame
Complete Response (no Episodes of Nausea or Vomiting)		Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
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
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm		Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Michele Yvette Halyard, MD, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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