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A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver

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ClinicalTrials.gov Identifier: NCT00803647
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : September 14, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Biological: cetuximab
Drug: 5-FU
Drug: oxaliplatin
Drug: leucovorin
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
52.8  (8.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
NA [1] 
[1]
Gender data were not collected.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
18
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).
Hide Description [Not Specified]
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 20 patients were included in this outcome measure.
Arm/Group Title Treatment
Hide Arm/Group Description:
mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75
(50.9 to 91.34)
2.Primary Outcome
Title Reported Adverse Events.
Hide Description 19 participants experienced at least one adverse event. There were a total of 95 adverse events reported. (Note: multiple occurrences of the same adverse event in one individual are counted only once.) Refer to the Adverse Events section for specifics. The Other Adverse Events section lists only those events occurring above 5% frequency.
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: adverse events
95
3.Secondary Outcome
Title Overall Survival (OS). Time From Study Entry Until Death From Any Cause.
Hide Description The percentage of patients alive at 18 months.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.8
(57.7 to 94.5)
4.Secondary Outcome
Title Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by PET/CT, CT scan, MRI or spiral CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective clinical Response Rate (cRR) = CR + PR during the 3 preoperative cycles, among the treated patients.
Time Frame 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85
(62.1 to 96.8)
5.Secondary Outcome
Title Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.
Hide Description [Not Specified]
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with R0 resection
Arm/Group Title Treatment
Hide Arm/Group Description:
mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: months
13.3
(5.5 to 23.2)
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   6/20 (30.00%)    
Blood and lymphatic system disorders   
anaemia   1/20 (5.00%)  1
Cardiac disorders   
arhythmia supraventricular   1/20 (5.00%)  1
Gastrointestinal disorders   
upper gastrointestinal haemorrhage   1/20 (5.00%)  1
General disorders   
thrombosis in device   1/20 (5.00%)  1
Hepatobiliary disorders   
hyperbilirubinaemia   1/20 (5.00%)  1
Infections and infestations   
septic shock   1/20 (5.00%)  1
wound infection   1/20 (5.00%)  1
Cavernous sinus thrombosis   1/20 (5.00%)  1
Injury, poisoning and procedural complications   
vascular access complication   2/20 (10.00%)  2
Investigations   
platelet count decreased   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
acute respiratory distress syndrome   1/20 (5.00%)  1
Pleural effusion   1/20 (5.00%)  1
Vascular disorders   
deep vein thrombosis   1/20 (5.00%)  1
venous thrombosis   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%) # Events
Total   19/20 (95.00%)    
Blood and lymphatic system disorders   
neutropenia   7/20 (35.00%)  7
anaemia   3/20 (15.00%)  3
leukopenia   3/20 (15.00%)  3
lymphopenia   2/20 (10.00%)  2
General disorders   
fatigue   2/20 (10.00%)  2
Immune system disorders   
hypersensitivity   3/20 (15.00%)  3
Investigations   
alanine aminotransferase increased   2/20 (10.00%)  2
aspartate aminotransferase increased   2/20 (10.00%)  2
blood alkaline phosphatase increased   2/20 (10.00%)  2
Metabolism and nutrition disorders   
decreased appetitie   2/20 (10.00%)  2
hyperglycaemia   2/20 (10.00%)  2
hypoalbuminaemia   2/20 (10.00%)  2
Nervous system disorders   
peripheral sensory neuropathy   3/20 (15.00%)  3
Skin and subcutaneous tissue disorders   
exfoliative rash   6/20 (30.00%)  6
dermatitis acneiform   4/20 (20.00%)  4
rash   2/20 (10.00%)  2
Indicates events were collected by systematic assessment
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
Name/Title: Diana Gosik, Director Department of Site and Study Management
Organization: NSABP Foundation
Phone: 412-339-5333
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00803647     History of Changes
Other Study ID Numbers: NSABP FC-6
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: October 19, 2015
Results First Posted: September 14, 2016
Last Update Posted: May 7, 2018