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Trial record 30 of 722 for:    colon cancer AND 5-FU

A Study of Bevacizumab Plus 5-Flurouracil (5-FU) Based Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01695772
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : July 28, 2016
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: 5-FU based doublet chemotherapy
Drug: bevacizumab
Enrollment 50
Recruitment Details  
Pre-assignment Details Protocol did not specify any particular 5-Flurouracil (5-FU) based doublet chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received standard 5-Flurouracil (5-FU) based chemotherapy plus bevacizumab 5 milligrams per kilograms (mg/kg) intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Period Title: Overall Study
Started 50
Completed 12
Not Completed 38
Reason Not Completed
Withdrawal by Subject             18
Progressive Disease             8
Investigator Decision             5
Lost to Follow-up             4
Protocol Violation             2
Unspecified Reason             1
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
56.1  (9.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
11
  22.0%
Male
39
  78.0%
1.Primary Outcome
Title Percentage of Participants Achieving Complete Resection (R0 Resection)
Hide Description R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.
Time Frame At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.0
(17.9 to 44.6)
2.Secondary Outcome
Title Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection)
Time Frame At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 7.1)
3.Secondary Outcome
Title Percentage of Participants Achieving Objective Response
Hide Description Objective response rate was defined as the percentage of participants who achieved either Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1. This is defined as the best response recorded from the start of trial treatment until disease progression (or death). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [≥] 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time Frame Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.0
(17.9 to 44.6)
4.Secondary Outcome
Title Number of Participants With Disease Progression or Relapse or Death
Hide Description According to RECIST v1.1 Progressive Disease is defined as a 20 % or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions.
Time Frame Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
28
5.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. Kaplan-Meier curves were used to display PFS.
Time Frame Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
12.06
(6.70 to 13.31)
6.Secondary Outcome
Title Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18
Hide Description Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. The probability was estimated by Kaplan Meier curve analysis.
Time Frame Months 3, 6, 9, 12, 15, and 18
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Number of participants analyzed equals (=) number of participants who had surgery.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: PP of being alive and progression free
3 Months
97.7
(84.9 to 99.7)
6 Months
76.4
(59.4 to 87.0)
9 Months
59.5
(40.8 to 74.0)
12 Months
51.5
(32.6 to 67.5)
15 Months
30.0
(14.0 to 47.9)
18 Months
21.4
(8.1 to 38.9)
7.Secondary Outcome
Title Number of Participants With Disease Relapse or Death
Hide Description [Not Specified]
Time Frame Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
20
8.Secondary Outcome
Title Disease Free Survival (DFS)
Hide Description Disease Free Survival (DFS) was defined as the time from complete resection of liver metastases to disease relapse or death, for participants who achieve complete resection after pre-operative treatment with standard 5-FU based doublet regimen plus bevacizumab.
Time Frame Complete resection date up to disease relapse or death until data cutoff on 12 May 2016 (up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; Here, number of participants analyzed = participants who underwent study specified surgery. Participants who underwent surgery but did not achieve complete resection were censored.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: months
8.48
(1.84 to 10.09)
9.Secondary Outcome
Title Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12
Hide Description [Not Specified]
Time Frame Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: PP of being alive and disease free
3 Months
80.0
(40.9 to 94.6)
6 Months
70.0
(32.9 to 89.2)
9 Months
40.0
(12.3 to 67.0)
12 Months
20.0
(3.1 to 47.5)
Time Frame Adverse events were recorded from the date of Screening until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%)
Total   4/50 (8.00%) 
Infections and infestations   
Abdominal infection * 1  1/50 (2.00%) 
Scrotal infection * 1  1/50 (2.00%) 
Investigations   
Alanine aminotransferase increased * 1  1/50 (2.00%) 
Aspartate aminotransferase increased * 1  1/50 (2.00%) 
Vascular disorders   
Deep vein thrombosis * 1  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab
Affected / at Risk (%)
Total   26/50 (52.00%) 
Blood and lymphatic system disorders   
Bone marrow failure * 1  6/50 (12.00%) 
Gastrointestinal disorders   
Nausea * 1  7/50 (14.00%) 
Vomiting * 1  4/50 (8.00%) 
General disorders   
Injection site reaction * 1  7/50 (14.00%) 
Investigations   
Alanine aminotransferase increased * 1  7/50 (14.00%) 
Aspartate aminotransferase increased * 1  7/50 (14.00%) 
Neutrophil count decreased * 1  7/50 (14.00%) 
White blood cell count decreased * 1  5/50 (10.00%) 
Vascular disorders   
Hypertension * 1  11/50 (22.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01695772     History of Changes
Other Study ID Numbers: ML28419
First Submitted: September 27, 2012
First Posted: September 28, 2012
Results First Submitted: June 17, 2016
Results First Posted: July 28, 2016
Last Update Posted: June 9, 2017