Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00100841
First received: January 6, 2005
Last updated: June 26, 2015
Last verified: July 2013
Results First Received: June 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Rectum
Mucinous Adenocarcinoma of the Colon
Recurrent Colon Cancer
Recurrent Rectal Cancer
Signet Ring Adenocarcinoma of the Colon
Stage IV Colon Cancer
Stage IV Rectal Cancer
Interventions: Biological: cetuximab
Biological: bevacizumab
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 67 patients were enrolled from between December 2004 and November 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient was enrolled but never started treatment

Reporting Groups
  Description
Treatment (Combination Chemotherapy)

Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

bevacizumab: Given IV

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV


Participant Flow:   Overall Study
    Treatment (Combination Chemotherapy)  
STARTED     66  
COMPLETED     66  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Combination Chemotherapy)

Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

bevacizumab: Given IV

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV


Baseline Measures
    Treatment (Combination Chemotherapy)  
Number of Participants  
[units: participants]
  66  
Age  
[units: years]
Median (Full Range)
  57  
  (27 to 82)  
Gender  
[units: participants]
 
Female     31  
Male     35  
Race/Ethnicity, Customized  
[units: participants]
 
White     51  
Black     10  
Asian     2  
Hispanic     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Severe Adverse Event (SAE) Rate   [ Time Frame: The duration of the study ]

2.  Primary:   Progression Free Survival Rate   [ Time Frame: From randomization to the first documented disease progression ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa Escobar-Peralta
Organization: Montefiore Medical Center
phone: 718-379-6866
e-mail: lescobar@montefiore.org


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00100841     History of Changes
Other Study ID Numbers: NCI-2012-03006
NCI-6490 ( Other Identifier: CTEP ID )
N01CM62201 ( US NIH Grant/Contract Award Number )
N01CM62204 ( US NIH Grant/Contract Award Number )
Study First Received: January 6, 2005
Results First Received: June 26, 2015
Last Updated: June 26, 2015
Health Authority: United States: Food and Drug Administration