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Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal 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: NCT00100841
Recruitment Status : Completed
First Posted : January 7, 2005
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 66
Recruitment Details A total of 67 patients were enrolled from between December 2004 and November 2006
Pre-assignment Details One patient was enrolled but never started treatment
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 66
Completed 66
Not Completed 0
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 66 participants
57
(27 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants
Female
31
  47.0%
Male
35
  53.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants
White 51
Black 10
Asian 2
Hispanic 3
1.Primary Outcome
Title Severe Adverse Event (SAE) Rate
Hide Description The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation
Time Frame The duration of the study
Hide Outcome Measure Data
Hide Analysis Population Description
66 patients treated with cetuximab
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
Grade 5 Death 2
Grade 4 venous thrombosis 2
2.Primary Outcome
Title Progression Free Survival Rate
Hide Description [Not Specified]
Time Frame From randomization to the first documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 38
Median (95% Confidence Interval)
Unit of Measure: months
9.6
(9.5 to 12.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Combination Chemotherapy)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Combination Chemotherapy)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment (Combination Chemotherapy)
Affected / at Risk (%) # Events
Total   54/66 (81.82%)    
Blood and lymphatic system disorders   
Hemoglobin (anemia)  2/66 (3.03%)  2
Neutropenia  15/66 (22.73%)  15
Cardiac disorders   
Cardiopulmonary-restrictive  1/66 (1.52%)  1
Hypotension  2/66 (3.03%)  2
Gastrointestinal disorders   
Constipation  1/66 (1.52%)  1
Diarrhea  9/66 (13.64%)  9
Oral mucositis  2/66 (3.03%)  2
Nausea  1/66 (1.52%)  1
Vomiting  3/66 (4.55%)  3
Abdominal pain  6/66 (9.09%)  6
General disorders   
Fatigue  9/66 (13.64%)  9
Infections and infestations   
Catheter-related infection  2/66 (3.03%)  2
Ungual (nails) infection  1/66 (1.52%)  1
Investigations   
Platelet count decreased  2/66 (3.03%)  2
Alkaline phosphatase  2/66 (3.03%)  2
Alanine transaminase  2/66 (3.03%)  2
Aspartate transaminase  1/66 (1.52%)  1
Metabolism and nutrition disorders   
Anorexia  2/66 (3.03%)  2
Hypoalbuminemia  1/66 (1.52%)  1
Hypomagnesemia  3/66 (4.55%)  3
Hypokalemia  1/66 (1.52%)  1
Hyperglycemia  2/66 (3.03%)  2
Nervous system disorders   
Cerebrovascular ischemia  1/66 (1.52%)  1
Neuropathy: Sensory  8/66 (12.12%)  8
Renal and urinary disorders   
Proteinuria  1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1/66 (1.52%)  1
Skin and subcutaneous tissue disorders   
Nail changes  2/66 (3.03%)  2
Rash: acne/acneiform  5/66 (7.58%)  5
Vascular disorders   
Thromboembolic event  1/66 (1.52%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Combination Chemotherapy)
Affected / at Risk (%) # Events
Total   63/66 (95.45%)    
Gastrointestinal disorders   
Hemorrhage: lower gastrointestinal  7/66 (10.61%)  7
Infections and infestations   
Eye infection  6/66 (9.09%)  6
Upper airway infection  5/66 (7.58%)  5
Upper tract infection  3/66 (4.55%)  3
Renal and urinary disorders   
Hemorrhage: urine  5/66 (7.58%)  5
Respiratory, thoracic and mediastinal disorders   
Hemorrhage: nose  12/66 (18.18%)  12
Cough  10/66 (15.15%)  10
Dyspnea  10/66 (15.15%)  10
Skin and subcutaneous tissue disorders   
Dry skin  11/66 (16.67%)  11
Hand-foot reaction  16/66 (24.24%)  16
Vascular disorders   
Hypertension  10/66 (15.15%)  10
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: Lisa Escobar-Peralta
Organization: Montefiore Medical Center
Phone: 718-379-6866
EMail: lescobar@montefiore.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00100841    
Other Study ID Numbers: NCI-2012-03006
NCI-6490 ( Other Identifier: CTEP ID )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62204 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2005
First Posted: January 7, 2005
Results First Submitted: June 26, 2015
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015