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Trial record 60 of 1000 for:    colon cancer AND resection

Adjuvant Aflibercept for Metastatic Colorectal Cancer (C261)

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: NCT01669720
Recruitment Status : Terminated (Lack of efficacy and enrollment)
First Posted : August 21, 2012
Results First Posted : March 10, 2016
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Lifespan
University of California, San Diego
Montefiore Medical Center
University of Florida
Sanofi
Information provided by (Responsible Party):
howard safran, Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Intervention Drug: Aflibercept
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aflibercept Observation
Hide Arm/Group Description

Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years

Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
Period Title: Overall Study
Started 7 3
Completed 7 3
Not Completed 0 0
Arm/Group Title Aflibercept Observation Total
Hide Arm/Group Description

Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years

Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention. Total of all reporting groups
Overall Number of Baseline Participants 7 3 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
2
  66.7%
9
  90.0%
>=65 years
0
   0.0%
1
  33.3%
1
  10.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 3 participants 10 participants
53.5
(46 to 61)
57
(44 to 75)
54.6
(44 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 10 participants
Female
5
  71.4%
1
  33.3%
6
  60.0%
Male
2
  28.6%
2
  66.7%
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 3 participants 10 participants
7 3 10
1.Primary Outcome
Title Number of Patients Who Progressed
Hide Description Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.
Time Frame Every 3 months until disease progression (for up to 2 years).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aflibercept Observation
Hide Arm/Group Description:

Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years

Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
Overall Number of Participants Analyzed 7 3
Measure Type: Number
Unit of Measure: participants
2 0
2.Secondary Outcome
Title Number of Participants Who Experienced a Toxicity Profile of Adjuvant Ziv-aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Perioperative Therapy (Regimen) and Surgical Resection/Ablation.
Hide Description Toxicity defined by CTCAE Version 4.0 toxicities
Time Frame Throughout study treatment until 30 days post off study, approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data table reflects total number of patients who experienced a toxicity on study.
Arm/Group Title Aflibercept Observation
Hide Arm/Group Description:

Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years

Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
Overall Number of Participants Analyzed 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
6
  85.7%
2
  66.7%
Time Frame Every 2 weeks until 30 days post last dose of drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aflibercept Observation
Hide Arm/Group Description

Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years

Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
All-Cause Mortality
Aflibercept Observation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aflibercept Observation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aflibercept Observation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/7 (85.71%)      2/3 (66.67%)    
Investigations     
HTN   6/7 (85.71%)  6 1/3 (33.33%)  1
Bronchial infection   1/7 (14.29%)  1 0/3 (0.00%)  0
UTI   1/7 (14.29%)  1 0/3 (0.00%)  0
ALK   4/7 (57.14%)  4 0/3 (0.00%)  0
Glu   6/7 (85.71%)  6 0/3 (0.00%)  0
proteinuria   2/7 (28.57%)  2 0/3 (0.00%)  0
PLT   1/7 (14.29%)  1 1/3 (33.33%)  1
AST   3/7 (42.86%)  3 1/3 (33.33%)  1
ALT   2/7 (28.57%)  2 1/3 (33.33%)  1
bruising   1/7 (14.29%)  1 0/3 (0.00%)  0
Hoarseness   2/7 (28.57%)  2 0/3 (0.00%)  0
akathisia/restlessness   1/7 (14.29%)  1 0/3 (0.00%)  0
cough   1/7 (14.29%)  1 0/3 (0.00%)  0
fever   1/7 (14.29%)  1 0/3 (0.00%)  0
rash   1/7 (14.29%)  1 0/3 (0.00%)  0
Anemia   2/7 (28.57%)  2 0/3 (0.00%)  0
fatigue   2/7 (28.57%)  2 0/3 (0.00%)  0
lymph   3/7 (42.86%)  3 0/3 (0.00%)  0
Sodium   3/7 (42.86%)  3 0/3 (0.00%)  0
Edema- localized   2/7 (28.57%)  2 0/3 (0.00%)  0
pain-hip/leg, mouth, abd   5/7 (71.43%)  5 0/3 (0.00%)  0
headache   2/7 (28.57%)  2 0/3 (0.00%)  0
mucositis   1/7 (14.29%)  1 0/3 (0.00%)  0
creatinine   1/7 (14.29%)  1 0/3 (0.00%)  0
WBC   2/7 (28.57%)  2 0/3 (0.00%)  0
dizziness   1/7 (14.29%)  1 0/3 (0.00%)  0
neuropathy   2/7 (28.57%)  2 0/3 (0.00%)  0
arthralgia   1/7 (14.29%)  1 0/3 (0.00%)  0
weight gain   1/7 (14.29%)  1 0/3 (0.00%)  0
constipation   1/7 (14.29%)  1 0/3 (0.00%)  0
vision-blurry   1/7 (14.29%)  1 0/3 (0.00%)  0
increased hemoglobin   1/7 (14.29%)  1 0/3 (0.00%)  0
insomnia   1/7 (14.29%)  1 0/3 (0.00%)  0
anorexia   1/7 (14.29%)  1 0/3 (0.00%)  0
Anxiety   1/7 (14.29%)  1 0/3 (0.00%)  0
Hypokalemia   1/7 (14.29%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Howard Safran, MD
Organization: Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
EMail: kayla_rosati@brown.edu
Layout table for additonal information
Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01669720     History of Changes
Other Study ID Numbers: BrUOG C261
First Submitted: August 7, 2012
First Posted: August 21, 2012
Results First Submitted: January 8, 2016
Results First Posted: March 10, 2016
Last Update Posted: April 12, 2019