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

October 20, 2017 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Moline, Illinois, United States, 61265
      • Moline, Illinois, United States, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, United States, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, United States, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, United States, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, United States, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, United States, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
      • Westville, Indiana, United States, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Bettendorf, Iowa, United States, 52722
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Michigan
      • Niles, Michigan, United States, 49120
        • Michiana Hematology Oncology PC - Niles
      • Saint Joseph, Michigan, United States, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, United States, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, United States, 55805
        • Miller - Dwan Medical Center
      • Fergus Falls, Minnesota, United States, 56537
        • Fergus Falls Medical Group, PA
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, United States, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, United States, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, United States, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, United States, 68131-2197
        • Creighton University Medical Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center at Altru Hospital
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • La Crosse, Wisconsin, United States, 54601
        • Franciscan Skemp Healthcare - La Crosse Campus
      • Manitowoc, Wisconsin, United States, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Door County Cancer Center at Door County Memorial Hospital
    • Wyoming
      • Casper, Wyoming, United States, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Study Plan

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

How is the study designed?

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
EXPERIMENTAL: Arm II
Patients receive palonosetron hydrochloride IV on days 1 and 4.
Drug: palonosetron hydrochloride
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Up to 2 years
Up to 2 years
Proportion of Patients Reporting Treatment Failure
Time Frame: Up to 2 years
Up to 2 years
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Time Frame: Up to 2 years
Up to 2 years
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michele Yvette Halyard, MD, Mayo Clinic

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 Major Dates

Study Start (ACTUAL)

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (ESTIMATE)

May 18, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2017

Last Update Submitted That Met QC Criteria

October 20, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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