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Phase II Trial Evaluating the Efficacy and Tolerability of Aprepitant & Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00381862
First received: September 26, 2006
Last updated: December 12, 2011
Last verified: July 2011
History of Changes
Results First Received: June 10, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Colorectal Cancer
Nausea and Vomiting
Interventions: Drug: aprepitant
Drug: dexamethasone
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: palonosetron hydrochloride
Procedure: quality-of-life assessment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aprepitant and Palonosetron

Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle

Palonosetron: 0.25 mg IV push on day 1 only

Participant Flow:   Overall Study
    Aprepitant and Palonosetron  
STARTED     54  
COMPLETED     44  
NOT COMPLETED     10  



  Baseline Characteristics
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Reporting Groups
  Description
Aprepitant and Palonosetron

Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle

Palonosetron: 0.25 mg IV push on day 1 only

Baseline Measures
    Aprepitant and Palonosetron  
Number of Participants  
[units: participants]
 		  54  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     12  
Age  
[units: years]
Mean ± Standard Deviation 		  55  ± 11.728  
Gender  
[units: participants]
 		 
Female     24  
Male     30  
Region of Enrollment  
[units: participants]
 		 
United States     54  



  Outcome Measures

1.  Primary:   Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.   [ Time Frame: Up to 24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy   [ Time Frame: Duration of time that the patient is on study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.   [ Time Frame: Duration of time the patient is on study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.   [ Time Frame: Duration of time patient is on study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy   [ Time Frame: within 5 days of chemotherapy ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Joseph Bubalo, PharmD, BCPS, BCOP
Organization: OHSU Knight Cancer Institute
phone: 503-494-1080
e-mail: bubaloj@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00381862     History of Changes
Other Study ID Numbers: CDR0000503649, OHSU-SOL-06006-LM, OHSU-IRB-2302
Study First Received: September 26, 2006
Results First Received: June 10, 2011
Last Updated: December 12, 2011
Health Authority: United States: Federal Government