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Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

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: NCT00321828
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : January 14, 2013
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: bevacizumab
Drug: fluorouracil
Drug: leucovorin
Drug: oxaliplatin
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Hide Arm/Group Description Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Period Title: Overall Study
Started 90
Completed 86
Not Completed 4
Reason Not Completed
Ineligible             3
No follow up data             1
Arm/Group Title Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Hide Arm/Group Description Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants
59  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
45
  50.0%
Male
45
  50.0%
1.Primary Outcome
Title Major Morbidity Related to the Intact Primary Tumor
Hide Description Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Hide Arm/Group Description:
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Overall Number of Participants Analyzed 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of major morbidity (%)
16.3
(7.6 to 25.1)
2.Secondary Outcome
Title Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration
Hide Description [Not Specified]
Time Frame Time from start of study through year 5
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery
Hide Description [Not Specified]
Time Frame Time from start of study through year 5
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery
Hide Description [Not Specified]
Time Frame Time from start of study through year 5
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery
Hide Description [Not Specified]
Time Frame Time from start of study through year 5
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0
Hide Description [Not Specified]
Time Frame Time from start of study through year 5
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival as Measured by Death From Any Cause
Hide Description [Not Specified]
Time Frame Time from start of study through year 5
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
 
Arm/Group Title Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Hide Arm/Group Description Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
All-Cause Mortality
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Affected / at Risk (%)
Total   1/89 (1.12%) 
Gastrointestinal disorders   
Diarrhea  1  1/89 (1.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Affected / at Risk (%)
Total   58/89 (65.17%) 
Blood and lymphatic system disorders   
Anemia  1  5/89 (5.62%) 
Gastrointestinal disorders   
Abdominal pain  1  6/89 (6.74%) 
Diarrhea  1  7/89 (7.87%) 
Nausea  1  6/89 (6.74%) 
General disorders   
Fatigue  1  14/89 (15.73%) 
Immune system disorders   
Anaphylaxis  1  9/89 (10.11%) 
Investigations   
Neutrophil count decreased  1  29/89 (32.58%) 
White blood cell decreased  1  6/89 (6.74%) 
Metabolism and nutrition disorders   
Anorexia  1  5/89 (5.62%) 
Dehydration  1  7/89 (7.87%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  14/89 (15.73%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  8/89 (8.99%) 
Vascular disorders   
Thromboembolic event  1  10/89 (11.24%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
Phone: 412-330-4600
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00321828     History of Changes
Other Study ID Numbers: NSABP C-10
U10CA012027 ( U.S. NIH Grant/Contract )
CDR0000463513 ( Other Identifier: NCI )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: October 31, 2012
Results First Posted: January 14, 2013
Last Update Posted: January 24, 2013