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

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ClinicalTrials.gov Identifier: NCT00903396
Recruitment Status : Terminated (Slow accrual)
First Posted : May 18, 2009
Results First Posted : February 1, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE May 15, 2009
First Posted Date  ICMJE May 18, 2009
Results First Submitted Date  ICMJE December 7, 2016
Results First Posted Date  ICMJE February 1, 2017
Last Update Posted Date November 24, 2017
Actual Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Complete Response (no Episodes of Nausea or Vomiting) [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2009)
Complete Response (no Episodes of Nausea or Vomiting)
Change History Complete list of historical versions of study NCT00903396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • 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 ]
  • Proportion of Patients Reporting Treatment Failure [ Time Frame: Up to 2 years ]
  • Tolerability and Adverse Events as Assessed by NCI CTC v 3.0 [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2009)
  • 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
  • Proportion of Patients Reporting Treatment Failure
  • Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
  • Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Official Title  ICMJE A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: palonosetron hydrochloride
    Given IV
  • Other: placebo
    Given IV
Study Arms  ICMJE
  • Experimental: Arm I
    Patients receive palonosetron hydrochloride IV on day 1.
    Intervention: Drug: palonosetron hydrochloride
  • Experimental: Arm II
    Patients receive palonosetron hydrochloride IV on days 1 and 4.
    Intervention: Drug: palonosetron hydrochloride
  • Placebo Comparator: Arm III
    Patients receive placebo IV on day 1.
    Intervention: Other: placebo
  • Placebo Comparator: Arm IV
    Patients receive placebo IV on days 1 and 4.
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2009)
75
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00903396
Other Study ID Numbers  ICMJE NCCTG-N08C2
NCI-2009-01109 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000642449 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Michele Yvette Halyard, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP