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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

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
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Period Title: Overall Study
Started 2 1 3 1
Completed 2 1 3 1
Not Completed 0 0 0 0
Arm/Group Title Arm I Arm II Arm III Arm IV Total
Hide Arm/Group Description

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0 0
Hide Baseline Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Complete Response (no Episodes of Nausea or Vomiting)
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Proportion of Patients Reporting Treatment Failure
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description:

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
 
Arm/Group Title Arm I Arm II Arm III Arm IV
Hide Arm/Group Description

Patients receive palonosetron hydrochloride IV on day 1.

palonosetron hydrochloride: Given IV

Patients receive palonosetron hydrochloride IV on days 1 and 4.

palonosetron hydrochloride: Given IV

Patients receive placebo IV on day 1.

placebo: Given IV

Patients receive placebo IV on days 1 and 4.

placebo: Given IV

All-Cause Mortality
Arm I Arm II Arm III Arm IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II Arm III Arm IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I Arm II Arm III Arm IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michele Halyard, M.D.
Organization: Mayo Clinic
Phone: 4803014567
EMail: mhalyard@mayo.edu
Layout table for additonal information
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) )
First Submitted: May 15, 2009
First Posted: May 18, 2009
Results First Submitted: December 7, 2016
Results First Posted: February 1, 2017
Last Update Posted: November 24, 2017