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Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus (BEV/EV)

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ClinicalTrials.gov Identifier: NCT00597506
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : August 16, 2012
Last Update Posted : December 27, 2012
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Adenocarcinoma
Interventions Drug: Bevacizumab
Drug: Everolimus
Enrollment 50
Recruitment Details The recruitment process started in October 2007 and was complete in April 2009. All subjects except one were enrolled at the Morris Cancer Clinic at Duke University Medical Center. One subject was enrolled at the Community Memorial Healthcenter in South Hill, Virgina which is a Duke Oncology Network clinical research site.
Pre-assignment Details  
Arm/Group Title Drug: Bevacizumab and Everolimus
Hide Arm/Group Description Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.
Period Title: Overall Study
Started 50
Completed 49
Not Completed 1
Reason Not Completed
Subject is being followed for survival             1
Arm/Group Title Bevacizumab and Everolimus
Hide Arm/Group Description Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  80.0%
>=65 years
10
  20.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
56  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
20
  40.0%
Male
30
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Overall Response
Hide Description Overall response is composed of complete responses and partial responses. Complete response (CR): disappearance of all target lesions; Partial response: at least a 30 percent decrease in the sum of the longest diameter of the target lesions taking as reference the baseline sum longest diameter. Response is assessed at each subject's restaging, approximately ever 2 months.
Time Frame Measured 1 month after the last treated subject came off treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.
Arm/Group Title Bevacizumab and Everolimus
Hide Arm/Group Description:
Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description 8 week PFS
Time Frame interval between start of treatment and 8-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.
Arm/Group Title Bevacizumab and Everolimus
Hide Arm/Group Description:
Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
Overall Number of Participants Analyzed 49
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.58
(0.46 to 0.68)
Time Frame Adverse events were collected from 26Oct2007 (date of enrollment of first subject) through 17 April2010 (30 days after the last subject completed study drug).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab and Everolimus
Hide Arm/Group Description Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
All-Cause Mortality
Bevacizumab and Everolimus
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab and Everolimus
Affected / at Risk (%) # Events
Total   27/50 (54.00%)    
Cardiac disorders   
atrial fibrillation  2  1/50 (2.00%)  1
Cardiopulmonary arrest  2  1/50 (2.00%)  1
Gastrointestinal disorders   
Dehydration  1  2/50 (4.00%)  4
Enterovesicular fistula  2  1/50 (2.00%)  1
Bowel Perforation  2  1/50 (2.00%)  1
Hemorrhage, GI rectum  2  1/50 (2.00%)  1
Abdominal abscess with anastomatic leak  2  1/50 (2.00%)  1
Small bowel obstruction and pain  2  1/50 (2.00%)  1
Aspiration  2  1/50 (2.00%)  1
Anorexia  2  1/50 (2.00%)  1
Disease progression/Death  2  1/50 (2.00%)  1
Dysphagia  2  1/50 (2.00%)  2
Vomiting  2  1/50 (2.00%)  2
Diarrhea  2  1/50 (2.00%)  2
General disorders   
Pain  2  1/50 (2.00%)  1
Shortness of breath/chest pain  2  1/50 (2.00%)  1
Abdominal pain  2  2/50 (4.00%)  2
Chest pain  2  1/50 (2.00%)  1
Infections and infestations   
Hypoxia  2  1/50 (2.00%)  1
Infection  2  1/50 (2.00%)  1
Metabolism and nutrition disorders   
Hyponatremia  2  1/50 (2.00%)  1
Hyperbilirubinemia  2  1/50 (2.00%)  1
Acute Renal failure  2  1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis  2  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2  1/50 (2.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI CTCAE ver 3.0
2
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab and Everolimus
Affected / at Risk (%) # Events
Total   48/50 (96.00%)    
Cardiac disorders   
Hypertension  1  9/50 (18.00%) 
Gastrointestinal disorders   
Mucositis/Proctitis  1 [1]  37/50 (74.00%) 
Metabolism and nutrition disorders   
Hypokalemia  1  7/50 (14.00%) 
Hyperglycemia  1  6/50 (12.00%) 
Alkaline phosphatase elevation  1  6/50 (12.00%) 
Hyperlipidemia  1  34/50 (68.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
All grades of mucositis and proctitis
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Herbert Hurwitz, MD
Organization: Duke University Medical Center
Phone: 919-668-1861
Responsible Party: Herbert Hurwitz, Duke University
ClinicalTrials.gov Identifier: NCT00597506     History of Changes
Other Study ID Numbers: Pro00001574
First Submitted: December 26, 2007
First Posted: January 18, 2008
Results First Submitted: July 10, 2012
Results First Posted: August 16, 2012
Last Update Posted: December 27, 2012