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Trial record 21 of 45 for:    colon cancer | ( Map: Hawaii, United States )

Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

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.
ClinicalTrials.gov Identifier: NCT00381862
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : August 10, 2011
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aprepitant and Palonosetron
Hide Arm/Group Description

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

Period Title: Overall Study
Started 54
Completed 44
Not Completed 10
Arm/Group Title Aprepitant and Palonosetron
Hide Arm/Group Description

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

Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
0
   0.0%
Between 18 and 65 years
42
  77.8%
>=65 years
12
  22.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
55  (11.728)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
24
  44.4%
Male
30
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
1.Primary Outcome
Title Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aprepitant and Palonosetron
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: Participants
54
2.Secondary Outcome
Title Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy
Hide Description [Not Specified]
Time Frame Duration of time that the patient is on study
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.
Hide Description [Not Specified]
Time Frame Duration of time the patient is on study
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Duration of time patient is on study
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy
Hide Description [Not Specified]
Time Frame within 5 days of chemotherapy
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aprepitant and Palonosetron
Hide Arm/Group Description

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

All-Cause Mortality
Aprepitant and Palonosetron
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aprepitant and Palonosetron
Affected / at Risk (%) # Events
Total   29/54 (53.70%)    
Blood and lymphatic system disorders   
Anemia  1/54 (1.85%)  11
Hyperglycemia  1/54 (1.85%)  7
Hypokalemia  2/54 (3.70%)  7
Neutropenia  4/54 (7.41%)  21
Gastrointestinal disorders   
Abdominal Pain  3/54 (5.56%)  10
Bowel Obstruction  1/54 (1.85%)  2
Diarrhea  1/54 (1.85%)  26
Diverticulitis  1/54 (1.85%) 
GI Perforation  1/54 (1.85%) 
Melena  2/54 (3.70%) 
General disorders   
Dehydration  1/54 (1.85%) 
Dizziness  1/54 (1.85%) 
Infections and infestations   
Infections  1/54 (1.85%)  13
Injury, poisoning and procedural complications   
Fall  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders   
Compression Fracture  1/54 (1.85%) 
Psychiatric disorders   
Decreased Mental Status  1/54 (1.85%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/54 (1.85%)  2
Skin and subcutaneous tissue disorders   
Rash  2/54 (3.70%)  10
Vascular disorders   
Syncope  1/54 (1.85%) 
Transient Ischemic Attack (TIA)  1/54 (1.85%) 
Venous Thromboembolism (VTE)  1/54 (1.85%)  7
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aprepitant and Palonosetron
Affected / at Risk (%) # Events
Total   18/54 (33.33%)    
Gastrointestinal disorders   
Heartburn/ Gastroesophageal Reflux Disease (GERD)  3/54 (5.56%)  10
General disorders   
Fatigue  7/54 (12.96%)  24
Nervous system disorders   
Neuropathy-Cold Related  3/54 (5.56%)  11
Neuropathy-Peripheral/Sensory  5/54 (9.26%)  18
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.
Results Point of Contact
Name/Title: Joseph Bubalo, PharmD, BCPS, BCOP
Organization: OHSU Knight Cancer Institute
Phone: 503-494-1080
Responsible Party: Joseph Bubalo, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00381862     History of Changes
Other Study ID Numbers: CDR0000503649
OHSU-SOL-06006-LM ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-IRB-2302 ( Other Identifier: OHSU IRB )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: June 10, 2011
Results First Posted: August 10, 2011
Last Update Posted: June 12, 2017