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VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00407654
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : August 18, 2015
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Intervention Drug: aflibercept
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VEGF Trap IV Arm I
Hide Arm/Group Description

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given intravenously

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Period Title: Overall Study
Started 75
Completed 75
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Baseline Participants 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 75 participants
59
(39 to 80)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
<=18 years
0
   0.0%
Between 18 and 65 years
54
  72.0%
>=65 years
21
  28.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
29
  38.7%
Male
46
  61.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants
Canada 49
United States 26
1.Primary Outcome
Title Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given intravenously

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: participants
1
2.Primary Outcome
Title Progression-free Survival (Bevacizumab- naïve Group)
Hide Description

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)

Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.7 to 8.6)
3.Primary Outcome
Title Progression-free Survival (Bevacizumab-treated Group)
Hide Description

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)

Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: months
2.4
(1.9 to 3.7)
4.Secondary Outcome
Title Overall Survival (Bevacizumab-naïve Group)
Hide Description Kaplan-Meier method will be used. (Bevacizumab- naïve Group)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given intravenously

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
10.4
(7.6 to 15.5)
5.Secondary Outcome
Title Overall Survival (Prior Bevacizumab Treated Group)
Hide Description Kaplan-Meier method will be used (Bevacizumab-naïve Group)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(6.2 to 10.6)
6.Secondary Outcome
Title Time to Progression
Hide Description Kaplan-Meier method will be used.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
data were not collected
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given intravenously

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Objective Stable Disease Rate
Hide Description [Not Specified]
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
data were not collected
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Response (Bevacizumab-naïve Group)
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;

Stable disease for atleast 16 weeks

Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
5
9.Secondary Outcome
Title Overall Survival (Bevacizumab-treated Group)
Hide Description Kaplan-Meier method will be used. (Bevacizumab-treated Group)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(6.2 to 10.6)
10.Secondary Outcome
Title Overall Survival (Bevacizumab-treated Group)
Hide Description Kaplan-Meier method will be used (Bevacizumab-treated Group)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(6.2 to 10.6)
11.Secondary Outcome
Title Number of Participants With Response (Bevacizumab-treated Group)
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;

Stable disease for atleast 16 weeks

Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

aflibercept: Given intravenously

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   19/75 (25.33%) 
Cardiac disorders   
Chest pain - cardiac   1/75 (1.33%) 
Sinus bradycardia   1/75 (1.33%) 
Gastrointestinal disorders   
Rectal pain   1/75 (1.33%) 
Rectal hemorrhage   1/75 (1.33%) 
Constipation   1/75 (1.33%) 
Abdominal pain   2/75 (2.67%) 
Dyspepsia   1/75 (1.33%) 
Esophageal pain   1/75 (1.33%) 
Esophageal varices hemorrhage   1/75 (1.33%) 
Colonic obstruction   1/75 (1.33%) 
Small intestinal obstruction   1/75 (1.33%) 
General disorders   
Weight loss   1/75 (1.33%) 
Pain   1/75 (1.33%) 
DeathNOS   1/75 (1.33%) 
Non-cardiac chest pain   2/75 (2.67%) 
Investigations   
Aspartate aminotransferase increased   1/75 (1.33%) 
Metabolism and nutrition disorders   
Dehydration   1/75 (1.33%) 
Musculoskeletal and connective tissue disorders   
Bone pain   1/75 (1.33%) 
Nervous system disorders   
Headache   1/75 (1.33%) 
Extrapyramidal disorder   1/75 (1.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   2/75 (2.67%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome   2/75 (2.67%) 
Vascular disorders   
Hypertension   2/75 (2.67%) 
Thromboembolic event   1/75 (1.33%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%)
Total   75/75 (100.00%) 
General disorders   
Fatigue   65/75 (86.67%) 
Vascular disorders   
Hypertension   48/75 (64.00%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Malcolm Moore
Organization: Princess Margaret Cancer Centre
Phone: 416-945-2263
EMail: malcolm.moore@uhn.ca
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00407654     History of Changes
Other Study ID Numbers: NCI-2009-00176
PHL-050 ( Other Grant/Funding Number: N01CM62203 )
CDR0000518293 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: December 4, 2006
First Posted: December 5, 2006
Results First Submitted: March 27, 2015
Results First Posted: August 18, 2015
Last Update Posted: August 24, 2018