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Trial record 30 of 104 for:    colon cancer | ( Map: Nebraska, United States )

Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00193219
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 7, 2013
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colon Cancer
Interventions Drug: Bevacizumab
Drug: Cetuximab
Drug: 5-fluorouracil
Drug: Leucovorin
Drug: Oxaliplatin
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab/Cetuximab/FOLFOX
Hide Arm/Group Description Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
Period Title: Overall Study
Started 36
Completed 6
Not Completed 30
Arm/Group Title Bevacizumab/Cetuximab/FOLFOX
Hide Arm/Group Description Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
55
(29 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
16
  44.4%
Male
20
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.
Arm/Group Title Bevacizumab/Cetuximab/FOLFOX
Hide Arm/Group Description:
Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
55
(36 to 73)
2.Secondary Outcome
Title Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Hide Description Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.
Arm/Group Title Bevacizumab/Cetuximab/FOLFOX
Hide Arm/Group Description:
Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: months
9
(8.3 to 15.2)
3.Secondary Outcome
Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Hide Description Measured from the date of first treatment until the date of death from any cause
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.
Arm/Group Title Bevacizumab/Cetuximab/FOLFOX
Hide Arm/Group Description:
Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: months
25.7
(15.4 to 27.6)
4.Secondary Outcome
Title Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab
Hide Description [Not Specified]
Time Frame 18 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab/Cetuximab/FOLFOX
Hide Arm/Group Description Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
All-Cause Mortality
Bevacizumab/Cetuximab/FOLFOX
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab/Cetuximab/FOLFOX
Affected / at Risk (%) # Events
Total   14/31 (45.16%)    
Eye disorders   
Blurred Vision  1  1/31 (3.23%)  1
Gastrointestinal disorders   
Pain - Gastrointestinal  1  2/31 (6.45%)  2
Hemorrhage  1  1/31 (3.23%)  1
Dehydration  1  1/31 (3.23%)  1
Pain - Abdominal  1  1/31 (3.23%)  1
Diarrhea  1  1/31 (3.23%)  1
Acute Appendicitis  1  1/31 (3.23%)  1
General disorders   
Multi Organ Failure  1  1/31 (3.23%)  1
Immune system disorders   
Allergic Reaction  1  2/31 (6.45%)  2
Infections and infestations   
Sepsis  1  1/31 (3.23%)  1
Febrile Neutropenia  1  1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Progressive Disease  1  3/31 (9.68%)  3
Nervous system disorders   
Mental Status  1  1/31 (3.23%)  1
Psychiatric disorders   
Dementia  1  1/31 (3.23%)  1
Renal and urinary disorders   
Pain - Renal/Genitourinary  1  1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders   
ARDS  1  1/31 (3.23%)  1
Surgical and medical procedures   
Chemoport Malfunction  1  1/31 (3.23%)  1
Vascular disorders   
Thrombosis/Thrombus/Embolism  1  4/31 (12.90%)  4
Venous Occlusion  1  1/31 (3.23%)  1
Indicates events were collected by systematic assessment
1
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/Cetuximab/FOLFOX
Affected / at Risk (%) # Events
Total   31/31 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  22/31 (70.97%)  150
Edema  1  8/31 (25.81%)  21
Leukocytes  1  22/31 (70.97%)  102
Neutropenia  1  29/31 (93.55%)  126
Platelets  1  23/31 (74.19%)  112
Cardiac disorders   
Cardiovascular  1  4/31 (12.90%)  10
Hypertension  1  3/31 (9.68%)  10
Eye disorders   
Blurred Vision  1  2/31 (6.45%)  4
Dry Eye  1  2/31 (6.45%)  16
Gastrointestinal disorders   
Anorexia  1  23/31 (74.19%)  87
Distension  1  2/31 (6.45%)  2
Constipation  1  16/31 (51.61%)  59
Cramping  1  2/31 (6.45%)  3
Dehydration  1  3/31 (9.68%)  4
Diarrhea  1  25/31 (80.65%)  126
Taste Alteration  1 [1]  6/31 (19.35%)  17
Esophagitis  1  5/31 (16.13%)  12
Hemorrhoids  1  4/31 (12.90%)  15
Indigestion  1  2/31 (6.45%)  2
Mouth Sore  1  2/31 (6.45%)  2
Mouth Ulcer  1  2/31 (6.45%)  4
Mucositis  1  15/31 (48.39%)  47
Nausea  1  26/31 (83.87%)  93
Sore mouth  1  2/31 (6.45%)  2
Taste Alteration  1  7/31 (22.58%)  19
Vomiting  1  16/31 (51.61%)  31
General disorders   
Chills  1  4/31 (12.90%)  8
Cold Sensitivity  1  10/31 (32.26%)  40
Fatigue  1  31/31 (100.00%)  285
Fever  1  7/31 (22.58%)  10
Hypersensitivity Reaction  1  6/31 (19.35%)  17
Insomnia  1  9/31 (29.03%)  35
Night Sweats  1  2/31 (6.45%)  5
Pain  1  23/31 (74.19%)  96
Weakness  1  7/31 (22.58%)  34
Hepatobiliary disorders   
AST  1  2/31 (6.45%)  3
Infections and infestations   
Febrile Neutropenia  1  3/31 (9.68%)  7
Infection  1 [2]  3/31 (9.68%)  4
Infection  1 [3]  4/31 (12.90%)  4
Metabolism and nutrition disorders   
Hyperglycemia  1  11/31 (35.48%)  36
Hypoalbuminemia  1  2/31 (6.45%)  8
Hypocalcemia  1  2/31 (6.45%)  3
Hypokalemia  1  4/31 (12.90%)  6
Hypomagnesemia  1  3/31 (9.68%)  10
Proteinuria  1  13/31 (41.94%)  34
Musculoskeletal and connective tissue disorders   
Arthralgia  1  8/31 (25.81%)  14
Myalgia  1  3/31 (9.68%)  3
Nervous system disorders   
Altered Mental Status  1  2/31 (6.45%)  3
Confusion  1  2/31 (6.45%)  3
Dizziness  1  2/31 (6.45%)  2
Headache  1  2/31 (6.45%)  2
Motor Neuropathy  1  2/31 (6.45%)  12
Sensory Neuropathy  1  23/31 (74.19%)  172
Psychiatric disorders   
Anxiety  1  4/31 (12.90%)  7
Depression  1  5/31 (16.13%)  8
Renal and urinary disorders   
Dysuria  1  3/31 (9.68%)  5
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  3/31 (9.68%)  8
Epistaxis  1  11/31 (35.48%)  35
Flu Syndrome  1  2/31 (6.45%)  5
Hiccoughs  1  2/31 (6.45%)  2
Pulmonary  1  7/31 (22.58%)  19
Runny Nose  1  2/31 (6.45%)  3
Sinus Drainage  1  2/31 (6.45%)  2
Sore Throat  1  4/31 (12.90%)  17
Skin and subcutaneous tissue disorders   
Alopecia  1  12/31 (38.71%)  71
Fingertip Fissures  1  2/31 (6.45%)  12
Nail Changes  1  5/31 (16.13%)  17
Hand-Foot  1  6/31 (19.35%)  17
Skin  1  29/31 (93.55%)  266
Vascular disorders   
Thrombosis/Thrombus/Embolism  1  3/31 (9.68%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Dysgeusia
[2]
Infection not otherwise specified
[3]
Sinus
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193219     History of Changes
Other Study ID Numbers: SCRI GI 64
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: December 7, 2012
Results First Posted: March 7, 2013
Last Update Posted: March 12, 2013