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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00903396
Recruitment Status : Terminated (Slow accrual)
First Posted : May 18, 2009
Results First Posted : February 1, 2017
Last Update Posted : November 24, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.

Condition or disease Intervention/treatment Phase
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 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
Actual Study Start Date : September 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : May 2013

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

Primary Outcome Measures :
  1. Complete Response (no Episodes of Nausea or Vomiting) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of Patients Reporting Treatment Failure [ Time Frame: Up to 2 years ]
  3. Tolerability and Adverse Events as Assessed by NCI CTC v 3.0 [ Time Frame: Up to 2 years ]
  4. Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00903396

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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
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Study Chair: Michele Yvette Halyard, MD Mayo Clinic
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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00903396    
Other Study ID Numbers: NCCTG-N08C2
NCI-2009-01109 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000642449 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 18, 2009    Key Record Dates
Results First Posted: February 1, 2017
Last Update Posted: November 24, 2017
Last Verified: October 2017
Keywords provided by Alliance for Clinical Trials in Oncology:
nausea and vomiting
gastrointestinal carcinoid tumor
anal cancer
carcinoma of the appendix
colon cancer
rectal cancer
extrahepatic bile duct cancer
gallbladder cancer
gastric cancer
liver and intrahepatic biliary tract cancer
pancreatic cancer
small intestine cancer
primary peritoneal cavity cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Stomach Neoplasms
Carcinoid Tumor
Anus Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Signs and Symptoms, Digestive
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal