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Trial record 70 of 723 for:    colon cancer AND 5-FU

Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients

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: NCT00354978
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : October 21, 2011
Last Update Posted : October 21, 2011
Sponsor:
Collaborators:
Genentech, Inc.
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: 5-Fluorouracil
Drug: Bevacizumab
Drug: Leucovorin
Drug: Irinotecan
Enrollment 49
Recruitment Details Recruitment Period: January 13, 2005 through January 31, 2007. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details Forty nine (49) patients were enrolled onto the study, and 6 patients did not meet inclusion criteria and were excluded.
Arm/Group Title FOLFIRI Plus Bevacizumab
Hide Arm/Group Description FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
Period Title: Overall Study
Started 43
Completed 43
Not Completed 0
Arm/Group Title FOLFIRI Plus Bevacizumab
Hide Arm/Group Description FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
57
(26 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
17
  39.5%
Male
26
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title Median Progression-free Survival (PFS)
Hide Description PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
Time Frame From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol.
Arm/Group Title FOLFIRI Plus Bevacizumab
Hide Arm/Group Description:
FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
Overall Number of Participants Analyzed 43
Median (95% Confidence Interval)
Unit of Measure: Months
12.8
(9.6 to 15.2)
Time Frame 3 years and 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FOLFIRI Plus Bevacizumab
Hide Arm/Group Description FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
All-Cause Mortality
FOLFIRI Plus Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FOLFIRI Plus Bevacizumab
Affected / at Risk (%)
Total   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFIRI Plus Bevacizumab
Affected / at Risk (%)
Total   43/43 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  19/43 (44.19%) 
Eye disorders   
Watery Eye  1  12/43 (27.91%) 
Gastrointestinal disorders   
Abdominal Pain  1  7/43 (16.28%) 
Constipation  1  6/43 (13.95%) 
Hemorrhage (Rectum)  1  6/43 (13.95%) 
Nausea  1  19/43 (44.19%) 
Vomiting  1  16/43 (37.21%) 
General disorders   
Fatigue  1  19/43 (44.19%) 
Headache  1  10/43 (23.26%) 
Mucositis (Oral Cavity)  1  11/43 (25.58%) 
Neuropathy (Sensory)  1  7/43 (16.28%) 
Pain (Muscle)  1  12/43 (27.91%) 
Serum Glutamic Oxaloacetic Transaminase (AST)  1  18/43 (41.86%) 
Sweating  1  5/43 (11.63%) 
Metabolism and nutrition disorders   
ALT,SGPT (Serum Glutamic Pyruvic Transaminase)  1  9/43 (20.93%) 
Alkaline Phosphatase  1  7/43 (16.28%) 
Hypertension  1  8/43 (18.60%) 
Neutrophils/Granulocytes (ANC/AGC)  1  14/43 (32.56%) 
Proteinuria  1  11/43 (25.58%) 
Reproductive system and breast disorders   
Hot Flashes  1  10/43 (23.26%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, Pulmonary (Nose)  1  19/43 (44.19%) 
Pulmonary (Other)  1  5/43 (11.63%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  22/43 (51.16%) 
Hand-Foot Syndrome  1  5/43 (11.63%) 
Vascular disorders   
Thrombosis (Embolism)  1  5/43 (11.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Scott Kopetz, MD Associate Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-2828
EMail: mjlim@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00354978     History of Changes
Other Study ID Numbers: 2004-0614
First Submitted: July 18, 2006
First Posted: July 20, 2006
Results First Submitted: June 14, 2011
Results First Posted: October 21, 2011
Last Update Posted: October 21, 2011