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A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab (FC-4)

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: NCT00845039
Recruitment Status : Terminated (Study terminated early 22Feb2010 with only 4 participants due to business reasons.)
First Posted : February 16, 2009
Results First Posted : June 1, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colon Cancer
Rectal Cancer
Interventions Biological: Cetuximab
Drug: Irinotecan
Biological: IMC-A12 (cixutumumab)
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description 500 milligrams per square meter (mg/m²) of Cetuximab administered by intravenous (IV) infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance. 500 mg/m² of Cetuximab administered by IV infusion then followed by 10 milligrams per kilogram (mg/kg) of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Period Title: Overall Study
Started 2 2
Received at Least 1 Dose of Study Drug 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan Total
Hide Arm/Group Description 500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance. 500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance. Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
52.0
(48 to 56)
59.5
(56 to 63)
55.8
(48 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
2
 100.0%
0
   0.0%
2
  50.0%
Male
0
   0.0%
2
 100.0%
2
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
2
 100.0%
4
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
 100.0%
2
  50.0%
White
2
 100.0%
0
   0.0%
2
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2
 100.0%
2
 100.0%
4
 100.0%
1.Primary Outcome
Title Progression-Free Survival (PFS) Rate at 18 Weeks
Hide Description [Not Specified]
Time Frame Approximately 18 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Objective Response Rate (ORR) [Complete Response (CR) + Partial Response (PR)]
Hide Description [Not Specified]
Time Frame Randomization up to 26.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Randomization up to 26.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression Free Survival (PFS) Over Entire Duration
Hide Description [Not Specified]
Time Frame Randomization up to 26.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title The Number of Participants Who Had a Complete Resection/Ablation of Metastases With no Evidence of Disease Remaining (Resection Rate)
Hide Description [Not Specified]
Time Frame Randomization up to 26.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Toxicity of the Irinotecan + Cetuximab + IMC-A12 Regimen
Hide Description [Not Specified]
Time Frame Randomization up to 26.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Post-treatment Serum Levels of IMC-A12 in Participants Receiving IMC-A12
Hide Description [Not Specified]
Time Frame Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in Behavioral and Health Outcomes [BAHO] Quality of Life (QoL) Questionnaire
Hide Description [Not Specified]
Time Frame Baseline, after Cycle 3 (14-day cycle), study discontinuation 30-day follow-up (up to 26.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Serum Anti-IMC-A12 Antibody Assessment
Hide Description [Not Specified]
Time Frame Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.
Arm/Group Title Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title The Number of Participants Who Died During 30-Day Follow-Up
Hide Description Reported are the deaths during the 30-day follow-up period regardless of causality.
Time Frame 26.3 months post-randomization up to 30-day post-treatment follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description:
500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance.
500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
Overall Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Hide Arm/Group Description 500 mg/m² of Cetuximab administered by IV infusion then followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day cycle until disease progression or participant intolerance. 500 mg/m² of Cetuximab administered by IV infusion then followed by 10 mg/kg of IMC-A12 IV followed by 180 mg/m² of Irinotecan by IV infusion on Day 1 of each 14-day until disease progression or participant intolerance.
All-Cause Mortality
Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/2 (50.00%)    
Blood and lymphatic system disorders     
Anaemia  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Gastrointestinal disorders     
Nausea  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Hepatobiliary disorders     
Bile duct obstruction  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Hyperbilirubinaemia  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Investigations     
Aspartate aminotransferase increased  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Blood creatinine increased  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Blood potassium increased  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Renal and urinary disorders     
Renal failure acute  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab + Irinotecan Cetuximab + IMC-A12 + Irinotecan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Abdominal pain lower  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Constipation  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Diarrhoea  1  1/2 (50.00%)  4 1/2 (50.00%)  3
Dyspepsia  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Mouth ulceration  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Nausea  1  1/2 (50.00%)  2 0/2 (0.00%)  0
Stomatitis  1  1/2 (50.00%)  2 0/2 (0.00%)  0
General disorders     
Fatigue  1  2/2 (100.00%)  4 0/2 (0.00%)  0
Infections and infestations     
Clostridial infection  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Investigations     
Aspartate aminotransferase increased  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Blood potassium increased  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Haemoglobin decreased  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Weight increased  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/2 (50.00%)  3 0/2 (0.00%)  0
Dehydration  1  1/2 (50.00%)  2 0/2 (0.00%)  0
Hyperkalaemia  1  0/2 (0.00%)  0 1/2 (50.00%)  1
Hypokalaemia  1  1/2 (50.00%)  1 1/2 (50.00%)  1
Hypomagnesaemia  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/2 (50.00%)  2 0/2 (0.00%)  0
Hypoaesthesia  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Neuropathy peripheral  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Paraesthesia  1  1/2 (50.00%)  2 0/2 (0.00%)  0
Peripheral sensory neuropathy  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Restless legs syndrome  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/2 (50.00%)  2 0/2 (0.00%)  0
Depression  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Insomnia  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Dyspnoea exertional  1  1/2 (50.00%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Dermatitis acneiform  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Palmar-plantar erythrodysaesthesia syndrome  1  0/2 (0.00%)  0 1/2 (50.00%)  2
Rash  1  1/2 (50.00%)  2 1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Study terminated early 22Feb2010 with only 4 participants due to business reasons. Data were collected for too few participants to draw statistically meaningful conclusions and included concerns on participant confidentiality.
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.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00845039     History of Changes
Other Study ID Numbers: 13928
CP13-0708 ( Other Identifier: ImClone, LLC )
I5A-IE-JAED ( Other Identifier: Eli Lilly and Company )
NSABP FC-4 ( Other Identifier: The National Surgical Adjuvant Breast and Bowel Project )
First Submitted: February 10, 2009
First Posted: February 16, 2009
Results First Submitted: March 17, 2018
Results First Posted: June 1, 2018
Last Update Posted: July 2, 2018