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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00903396
First received: May 15, 2009
Last updated: December 7, 2016
Last verified: December 2016
Results First Received: December 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: 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
Interventions: Drug: palonosetron hydrochloride
Other: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Arm II

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Arm III

Patients receive placebo IV on day 1.

placebo: Given IV

Arm IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV


Participant Flow:   Overall Study
    Arm I   Arm II   Arm III   Arm IV
STARTED   2   1   3   1 
COMPLETED   2   1   3   1 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.

Reporting Groups
  Description
Arm I

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Arm II

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Arm III

Patients receive placebo IV on day 1.

placebo: Given IV

Arm IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Arm III   Arm IV   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0   0   0 
Gender           
Female               0 
Male               0 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   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 ]

3.  Secondary:   Proportion of Patients Reporting Treatment Failure   [ Time Frame: Up to 2 years ]

4.  Secondary:   Tolerability and Adverse Events as Assessed by NCI CTC v 3.0   [ Time Frame: Up to 2 years ]

5.  Secondary:   Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michele Halyard, M.D.
Organization: Mayo Clinic
phone: 4803014567
e-mail: mhalyard@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00903396     History of Changes
Other Study ID Numbers: NCCTG-N08C2
NCI-2009-01109 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000642449 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: May 15, 2009
Results First Received: December 7, 2016
Last Updated: December 7, 2016