Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 4998 for:    colon cancer

Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer

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: NCT00826800
Recruitment Status : Terminated (Lack of accrual)
First Posted : January 22, 2009
Results First Posted : April 15, 2015
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colon Cancer
Intervention Drug: FOLFOX and bevacizumab
Enrollment 2
Recruitment Details Protocol Open to Accrual: 01/19/2009 Protocol Closed to Accrual: 04/13/2010 Primary Completion Date (if applicable): 12/28/2010 Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title Neoadjuvant FOLFOX Plus Bevacizumab
Hide Arm/Group Description FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Neoadjuvant FOLFOX Plus Bevacizumab
Hide Arm/Group Description FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant.
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neoadjuvant FOLFOX Plus Bevacizumab
Hide Arm/Group Description:
FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Complete Response 1
Partial Response 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neoadjuvant FOLFOX Plus Bevacizumab
Hide Arm/Group Description FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
All-Cause Mortality
Neoadjuvant FOLFOX Plus Bevacizumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Neoadjuvant FOLFOX Plus Bevacizumab
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neoadjuvant FOLFOX Plus Bevacizumab
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/2 (100.00%)  19
Investigations   
Alanine aminotransferase increased  1  1/2 (50.00%)  1
Aspartate aminotransferase increased  1  1/2 (50.00%)  2
Alkaline phosphatase increased  1  1/2 (50.00%)  2
White blood cell decreased  1  1/2 (50.00%)  4
Platelet count decreased  1  1/2 (50.00%)  4
Metabolism and nutrition disorders   
Hypoalbuminemia  1  2/2 (100.00%)  4
Hypercalcemia  1  1/2 (50.00%)  1
Hyperglycemia  1  2/2 (100.00%)  13
Hyperkalemia  1  2/2 (100.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Early termination lead to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Leonard Saltz
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4286
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00826800     History of Changes
Other Study ID Numbers: 08-162
First Submitted: January 20, 2009
First Posted: January 22, 2009
Results First Submitted: April 3, 2015
Results First Posted: April 15, 2015
Last Update Posted: April 15, 2015