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Trial record 75 of 723 for:    colon cancer AND 5-FU

Study of IMC-11F8 in Participants 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: NCT00835185
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : January 29, 2016
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Biological: IMC-11F8 (necitumumab)
Drug: Oxaliplatin
Drug: Folinic acid (FA)
Drug: 5-FU
Enrollment 44
Recruitment Details  
Pre-assignment Details Participants with known best overall response and off study treatment were considered to be completed.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes
  • 85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met.
Period Title: Overall Study
Started 44
Received at Least 1 Dose of Study Drug 44
Completed 44
Not Completed 0
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
All enrolled participants who received any quantity of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
63.3  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
19
  43.2%
Male
25
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Hispanic or Latino
31
  70.5%
Not Hispanic or Latino
13
  29.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.5%
White
42
  95.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
Belgium 13
Spain 31
1.Primary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
Hide Description CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100.
Time Frame Up to 30 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.6
(47.8 to 77.6)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.
Time Frame First dose to date of death from any cause up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug. Participants censored =14.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: months
22.5
(11.0 to 30.0)
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.
Time Frame First dose to measured PD or death up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug. Participants censored =13.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(7.0 to 12.0)
4.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death
Hide Description The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time Frame First dose to end of treatment and 30-day post treatment follow-up up to 31 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: participants
AEs 44
SAEs 16
Deaths 3
5.Secondary Outcome
Title Duration of Response
Hide Description The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.
Time Frame Time of response to time of measured PD or death up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: months
10.0
(7.0 to 16.0)
6.Secondary Outcome
Title Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)
Hide Description A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.
Time Frame Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
4
7.Secondary Outcome
Title Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug and had pharmacokinetic (PK) data available to calculate Cmax.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes;
  • 85 mg/m² oxaliplatin IV infusion over 2 hours;
  • 400 mg/m² folinic acid;
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 39
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (µg/mL)
344
(46%)
8.Secondary Outcome
Title Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug and had PK data available to calculate AUC(0-∞).
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes;
  • 85 mg/m² oxaliplatin IV infusion over 2 hours;
  • 400 mg/m² folinic acid;
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour/milliliter (µg*h/mL)]
39400
(35%)
9.Secondary Outcome
Title Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1
Hide Description The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.
Time Frame Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug and had PK data available to calculate t1/2.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes;
  • 85 mg/m² oxaliplatin IV infusion over 2 hours;
  • 400 mg/m² folinic acid;
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 17
Geometric Mean (Full Range)
Unit of Measure: hours (h)
142
(99.8 to 299)
10.Secondary Outcome
Title Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1
Hide Description CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.
Time Frame Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug and had PK data available to calculate CL.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes;
  • 85 mg/m² oxaliplatin IV infusion over 2 hours;
  • 400 mg/m² folinic acid;
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliters/hour (mL/h)
20.3
(35%)
11.Secondary Outcome
Title Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1
Hide Description Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.
Time Frame Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received any quantity of study drug and had PK data available to calculate Vss.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes;
  • 85 mg/m² oxaliplatin IV infusion over 2 hours;
  • 400 mg/m² folinic acid;
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliters (mL)
3660
(32%)
12.Secondary Outcome
Title Cmax at Study Day 1 of Cycles 2 Through 6
Hide Description [Not Specified]
Time Frame Day 1 Cycles 2 through 6 predose and 1 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, Cmax results were not collected.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6
Hide Description [Not Specified]
Time Frame Day 1 Cycles 2 through 6 predose and 1 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, AUC results were not collected.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title t1/2 at Study Day 1 of Cycles 2 Through 6
Hide Description [Not Specified]
Time Frame Day 1 Cycles 2 through 6 predose and 1 hour post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, t1/2 results were not collected.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title CL at Study Day 1 of Cycles 2 Through 6
Hide Description [Not Specified]
Time Frame Day 1 Cycles 2 through 6 predose and 1 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, CL results were not collected.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Vss at Study Day 1 of Cycles 2 Through 6
Hide Description [Not Specified]
Time Frame Day 1 Cycles 2 through 6 predose and 1 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, Vss results were not collected.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Change From Baseline in Tumor Size
Hide Description [Not Specified]
Time Frame Baseline, 29 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, the outcome measure was registered in error.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Kirsten Rat Sarcoma (KRAS) Mutation Status
Hide Description Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had assessment of tumor tissue samples at baseline.
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
Hide Arm/Group Description:

On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes
  • 85 mg/m² oxaliplatin IV infusion over 2 hours
  • 400 mg/m² folinic acid
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
KRAS Mutation Positive 9
KRAS Mutation Negative 16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IMC-11F8 (Necitumumab) + mFOLFOX-6
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On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:

  • 800 mg IMC-11F8 IV infusion over 50 minutes;
  • 85 mg/m² oxaliplatin IV infusion over 2 hours;
  • 400 mg/m² folinic acid;
  • 400 mg/m² 5-FU as an IV bolus injection; and immediately followed by
  • A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met.
All-Cause Mortality
IMC-11F8 (Necitumumab) + mFOLFOX-6
Affected / at Risk (%)
Total   --/--    
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IMC-11F8 (Necitumumab) + mFOLFOX-6
Affected / at Risk (%) # Events
Total   16/44 (36.36%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/44 (2.27%)  1
Diarrhoea  1  2/44 (4.55%)  3
Gastrointestinal obstruction  1  1/44 (2.27%)  1
Intestinal obstruction  1  3/44 (6.82%)  5
Large intestine perforation  1  1/44 (2.27%)  1
Rectal haemorrhage  1  1/44 (2.27%)  1
Vomiting  1  1/44 (2.27%)  1
General disorders   
General physical health deterioration  1  1/44 (2.27%)  1
Medical device complication  1  1/44 (2.27%)  1
Pyrexia  1  1/44 (2.27%)  1
Thrombosis in device  1  1/44 (2.27%)  1
Immune system disorders   
Hypersensitivity  1  1/44 (2.27%)  1
Infections and infestations   
Sepsis  1  1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/44 (2.27%)  1
Psychiatric disorders   
Confusional state  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Organising pneumonia  1  1/44 (2.27%)  1
Respiratory failure  1  1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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Frequency Threshold for Reporting Other Adverse Events 5%
IMC-11F8 (Necitumumab) + mFOLFOX-6
Affected / at Risk (%) # Events
Total   44/44 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  9/44 (20.45%)  15
Neutropenia  1  23/44 (52.27%)  61
Thrombocytopenia  1  5/44 (11.36%)  30
Eye disorders   
Conjunctivitis  1  11/44 (25.00%)  17
Gastrointestinal disorders   
Abdominal pain  1  3/44 (6.82%)  4
Abdominal pain upper  1  5/44 (11.36%)  7
Constipation  1  13/44 (29.55%)  18
Diarrhoea  1  24/44 (54.55%)  60
Dyspepsia  1  5/44 (11.36%)  9
Nausea  1  17/44 (38.64%)  33
Oesophagitis  1  3/44 (6.82%)  4
Rectal tenesmus  1  3/44 (6.82%)  4
Stomatitis  1  8/44 (18.18%)  16
Vomiting  1  16/44 (36.36%)  31
General disorders   
Asthenia  1  36/44 (81.82%)  110
Fatigue  1  4/44 (9.09%)  5
Mucosal inflammation  1  19/44 (43.18%)  67
Pyrexia  1  9/44 (20.45%)  15
Immune system disorders   
Hypersensitivity  1  3/44 (6.82%)  4
Infections and infestations   
Paronychia  1  16/44 (36.36%)  45
Respiratory tract infection  1  3/44 (6.82%)  3
Urinary tract infection  1  3/44 (6.82%)  3
Investigations   
Weight decreased  1  14/44 (31.82%)  20
Weight increased  1  7/44 (15.91%)  11
Metabolism and nutrition disorders   
Decreased appetite  1  18/44 (40.91%)  34
Hypomagnesaemia  1  5/44 (11.36%)  9
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/44 (6.82%)  3
Back pain  1  8/44 (18.18%)  14
Pain in extremity  1  3/44 (6.82%)  5
Nervous system disorders   
Dysaesthesia  1  13/44 (29.55%)  46
Dysgeusia  1  7/44 (15.91%)  12
Headache  1  4/44 (9.09%)  5
Neuropathy peripheral  1  3/44 (6.82%)  5
Neurotoxicity  1  9/44 (20.45%)  15
Paraesthesia  1  16/44 (36.36%)  50
Peripheral sensory neuropathy  1  10/44 (22.73%)  54
Psychiatric disorders   
Insomnia  1  3/44 (6.82%)  7
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/44 (6.82%)  3
Dyspnoea  1  5/44 (11.36%)  6
Epistaxis  1  4/44 (9.09%)  4
Skin and subcutaneous tissue disorders   
Alopecia  1  10/44 (22.73%)  11
Dermatitis acneiform  1  5/44 (11.36%)  6
Dry skin  1  8/44 (18.18%)  10
Palmar-plantar erythrodysaesthesia syndrome  1  10/44 (22.73%)  24
Pruritus  1  5/44 (11.36%)  5
Rash  1  31/44 (70.45%)  104
Skin fissures  1  10/44 (22.73%)  23
Vascular disorders   
Hypotension  1  3/44 (6.82%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00835185     History of Changes
Other Study ID Numbers: 13926
2006-003147-23 ( EudraCT Number )
CP11-0602 ( Other Identifier: ImClone Systems )
I4X-IE-JFCD ( Other Identifier: Eli Lilly and Company )
First Submitted: February 2, 2009
First Posted: February 3, 2009
Results First Submitted: December 21, 2015
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016