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Trial record 53 of 167 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced 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: NCT00940316
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Genentech, Inc.
OSI Pharmaceuticals
Amgen
Information provided by (Responsible Party):
Al Benson, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: panitumumab
Drug: erlotinib hydrochloride
Drug: irinotecan hydrochloride
Enrollment 28
Recruitment Details The study opened for accrual on July 9, 2009 with an accrual goal of up to 96 patients. The study was designed to enroll 13 patients on each arm and do an interim efficacy assessment. Accrual was suspended on March 31 2015 fand closed permanently on April 13, 2015 with 28 patients enrolled on the study.
Pre-assignment Details Subjects with either 6/6 UGT1A1 genotype or 6/7 UGT1A1 genotype will be randomized into either Arm A and Arm B. Subjects with 7/7 UGT1A1 genotype enrolled in Arm C.
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab
Hide Arm/Group Description

Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Period Title: Reached First Response at 8 Weeks
Started 13 13 2
Completed 10 9 2
Not Completed 3 4 0
Reason Not Completed
Adverse Event             2             1             0
Progressive disease             1             3             0
Period Title: Moved on to be Treated Cycle 5
Started 10 9 2
Completed 8 9 2
Not Completed 2 0 0
Reason Not Completed
Adverse Event             2             0             0
Period Title: Treated After Cycle 5
Started 8 9 2
Completed 8 8 1
Not Completed 0 1 1
Reason Not Completed
Adverse Event             0             0             1
Progressive disease             0             1             0
Period Title: Crossed Over to Arm A After Progression
Started [1] 0 3 0
Treated for Cycle One 0 3 0
Completed 0 3 0
Not Completed 0 0 0
[1]
Patients on Arm B that progressed were able to cross over and be treated on arm A if still eligible.
Period Title: Follow up Every 3 Months
Started [1] 13 13 2
Completed 13 13 2
Not Completed 0 0 0
[1]
All patients that receive treatment on the study go into follow up at treatment completion.
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab Total
Hide Arm/Group Description

Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Total of all reporting groups
Overall Number of Baseline Participants 13 13 2 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  61.5%
9
  69.2%
2
 100.0%
19
  67.9%
>=65 years
5
  38.5%
4
  30.8%
0
   0.0%
9
  32.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
Female
6
  46.2%
5
  38.5%
0
   0.0%
11
  39.3%
Male
7
  53.8%
8
  61.5%
2
 100.0%
17
  60.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
Hispanic or Latino
3
  23.1%
2
  15.4%
0
   0.0%
5
  17.9%
Not Hispanic or Latino
10
  76.9%
11
  84.6%
2
 100.0%
23
  82.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
1
   7.7%
1
  50.0%
3
  10.7%
White
12
  92.3%
12
  92.3%
1
  50.0%
25
  89.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
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 13 participants 13 participants 2 participants 28 participants
13 13 2 28
UGT1A1 genotyping 6/6  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
9 7 0 16
UGT1A1 genotyping 6/7  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
4 6 0 10
UGT1A1 genotyping 7/7  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 2 participants 28 participants
0 0 2 2
1.Primary Outcome
Title Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
Hide Description

Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions.

Complete Response (CR): Disappearance of all target lesions.

Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD.

Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

Time Frame At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab
Hide Arm/Group Description:

Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Overall Number of Participants Analyzed 13 13 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
1
   7.7%
0
   0.0%
Partial Response
4
  30.8%
3
  23.1%
0
   0.0%
Stable disease
6
  46.2%
3
  23.1%
2
 100.0%
2.Secondary Outcome
Title Time to Disease Progression
Hide Description

Time to disease progression will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression . Time to disease progression will be defined as the time elapsed from the day of 1st study drug administration to the day disease progression is documented or death occurs and will .

Progressive Disease will be defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) : At least a 20% increase in the sum of the longest diameter (LD) of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time Frame At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patient data analyzed reported together regardless of arm allocation. Data not collected and analyzed for this outcome measure.
Arm/Group Title Arm A + Arm B + Arm C
Hide Arm/Group Description:

Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure will be measured as the time elapsed from the day of first study drug administration to the date a subject stops all study drugs for any reason.
Time Frame From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and analyzed for this outcome measure
Arm/Group Title Arm A + Arm B + Arm C
Hide Arm/Group Description:

Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity of the Combination of Study Drugs
Hide Description

Data on the toxicity of the combination of study drugs is assessed by laboratory blood draws done on day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 3 and grade 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected using National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). AEs are graded as:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Time Frame Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Hide Arm/Group Description:

Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.

Overall Number of Participants Analyzed 13 10 2 3
Measure Type: Number
Unit of Measure: participants
Hemoglobin decrease 3 1 0 0
Leukocyte decrease 7 0 1 0
Lymphopenia 1 0 0 0
Neutrophil decrease 7 0 1 0
Fatigue 1 1 1 0
Dry skin 1 0 0 0
Rash/desquamation 0 0 1 0
Rash: Hand-foot skin reaction 4 7 2 0
Anorexia 1 0 0 0
Diarrhea 6 0 1 0
Nausea 1 0 1 0
Infection 1 0 0 0
Alkaline phosphatase decrease 0 2 0 0
Magnesium decrease 5 4 1 0
Phosphate decrease 2 1 3 0
Sodium decrease 1 0 0 0
Syncope/fainting 1 0 0 0
Pruritus/itching 0 1 0 0
5.Secondary Outcome
Title Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition
Hide Description Effect on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition. Skin biopsies will be performed at baseline (before the first days of treatment) and and at a time-point reflecting maximum rash intensity determined by a dermatologist.
Time Frame At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles.
Hide Outcome Measure Data
Hide Analysis Population Description
All patient data analyzed reported together regardless of arm allocation.This outcome measure was based on optional biopsies that patients were required to consent to. Data was not collected or analyzed for this outcome measure.
Arm/Group Title Arm A + Arm B + Arm C
Hide Arm/Group Description:

Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Post-Hoc Outcome
Title Median Overall Survival
Hide Description Median Overall Survival (OS) is measured from treatment initiation until death due to any cause.
Time Frame From the time of first treatment to death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab
Hide Arm/Group Description:

Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Overall Number of Participants Analyzed 13 13 2
Median (95% Confidence Interval)
Unit of Measure: Months
12.6
(4.8 to 19.4)
8.6
(3.1 to 30.1)
2.4 [1] 
(NA to NA)
[1]
Sample size to small to calculate confidence interval
7.Post-Hoc Outcome
Title Progression Free Survival (PFS)
Hide Description

Progression free survival will be measured every 8 weeks during treatment by CT or MRI scans. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST).

Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time Frame At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab
Hide Arm/Group Description:

Arm A - Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Irinotecan hydrochloride: Given intravenously 120mg/m2 every 2 weeks

Arm B - Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Overall Number of Participants Analyzed 12 13 2
Median (95% Confidence Interval)
Unit of Measure: Months
4.6
(1.4 to 8.2)
3.8
(1.5 to 5.9)
2.4 [1] 
(NA to NA)
[1]
Sample size too small to calculate confidence interval
Time Frame Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Hide Arm/Group Description

Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

Patients receive erlotinib hydrochloride and panitumumab as in arm B.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Upon disease progression, patients receive irinotecan hydrochloride as in arm A.

panitumumab: Given intravenously 6mg/kg every 2 weeks

erlotinib hydrochloride: Given orally 150mg daily

irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype

After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle.

All-Cause Mortality
Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/13 (84.62%)      10/10 (100.00%)      1/2 (50.00%)      3/3 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/13 (23.08%)      4/10 (40.00%)      1/2 (50.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders         
Neutropenic fever  1 [1]  1/13 (7.69%)  1 0/10 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Diarrhea  1 [2]  0/13 (0.00%)  0 0/10 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Small bowel obstruction  1 [3]  1/13 (7.69%)  1 0/10 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Gastritis  1  0/13 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Partial Small Bowel Obstruction  1 [4]  0/13 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations         
Pneumonia  1 [5]  0/13 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Bronchitis  1 [6]  0/13 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Investigations         
Hypoglycemia  1  0/13 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  0/13 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Death NOS- progressive disease  1 [7]  1/13 (7.69%)  1 0/10 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Altered mental status  1  0/13 (0.00%)  0 1/10 (10.00%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders         
Urinary Track infection  1  0/13 (0.00%)  0 0/10 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
Patient also experienced diarrhea, sepsis and rash during this hospital admission
[2]
Patient admitted for diarrhea but also had fatigue, neutropenic fever, nausea and vomiting during the hospital admission.
[3]
Patient also experienced decreased white blood cell count
[4]
Patient also experienced anemia and colonic fistula during this hospital admission.
[5]
Patient also experienced anemia during this hospital admission
[6]
Patient also experiences esophagitis during this hospital admission
[7]
Patient also experienced drug induced pneumonitis during this hospital admission
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Erlotinib + Panitumumab + Irinotecan Arm B: Erlotinib + Panitumumab Arm C: Erlotinib + Panitumumab Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      10/10 (100.00%)      2/2 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders         
Hemoglobin (Anemia)  1  9/13 (69.23%)  8/10 (80.00%)  1/2 (50.00%)  2/3 (66.67%) 
Neutrophils (neutropenia)  1  6/13 (46.15%)  1/10 (10.00%)  0/2 (0.00%)  1/3 (33.33%) 
Leukocytes (total white blood cells)  1  9/13 (69.23%)  1/10 (10.00%)  0/2 (0.00%)  1/3 (33.33%) 
lymphopenia  1  6/13 (46.15%)  2/10 (20.00%)  0/2 (0.00%)  0/3 (0.00%) 
Platelets (thrombocytopenia)  1  2/13 (15.38%)  1/10 (10.00%)  0/2 (0.00%)  1/3 (33.33%) 
Elevated BUN  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Edema - limb  1  0/13 (0.00%)  2/10 (20.00%)  0/2 (0.00%)  0/3 (0.00%) 
Cardiac disorders         
Hypertension  1  4/13 (30.77%)  2/10 (20.00%)  0/2 (0.00%)  0/3 (0.00%) 
Hypotension  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Ear and labyrinth disorders         
Hearing: patients without baseline audiogram and not enrolled in a monitoring  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Otitis, external ear (non-infectious)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Endocrine disorders         
Glucose intolerance  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Eye disorders         
Dry eye  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Blurred vision  1  0/13 (0.00%)  0/10 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Eye lesion  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Eye irritation  1  0/13 (0.00%)  0/10 (0.00%)  1/2 (50.00%)  0/3 (0.00%) 
Meibomian gland dysfunction  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Blepharitis  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Cloudy vision  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Eythema/conjunctive  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Conjunctivitis  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders         
Anorexia  1  4/13 (30.77%)  1/10 (10.00%)  0/2 (0.00%)  1/3 (33.33%) 
Constipation  1  5/13 (38.46%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Diarrhea  1  9/13 (69.23%)  5/10 (50.00%)  0/2 (0.00%)  3/3 (100.00%) 
Distension/bloating of abdomen  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Mucositis/stomatitis  1  4/13 (30.77%)  0/10 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Heartburn (dyspepsia)  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Nausea  1  7/13 (53.85%)  3/10 (30.00%)  0/2 (0.00%)  2/3 (66.67%) 
Taste alteration (dysgeusia)  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Vomiting  1  3/13 (23.08%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Retal burning  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Colon cancer with liver metastasis and likely bone metastasis  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Hemorrhoids  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
General disorders         
Fatigue  1  8/13 (61.54%)  4/10 (40.00%)  0/2 (0.00%)  1/3 (33.33%) 
Fever  1  3/13 (23.08%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Insomnia  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Rigors  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Weight loss  1  2/13 (15.38%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Nosebleed  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Rectum pain  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Flank pain  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Pain NOS  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Oral dysesthesia  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Infections and infestations         
Infection in pelvis (with normal ANC or grade 1 or 2 neutrophils)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Infection in upper airway (with normal ANC or Grade 1 or 2 neutrophils)  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Infection in abdomen (with normal ANC or Grade 1 or 2 neutrophils)  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Infection in urinary tract (unknown ANC)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Paronychia (infection with grade 3 or 4 neutrophils)  1  0/13 (0.00%)  0/10 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Skin infection (Cellulitis)  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  1/3 (33.33%) 
Ear infection  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Pseudomonas Bactermia  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Escherichia coli  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Investigations         
International Normalized Ratio of prothrombin time (INR)  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders         
Albumin, serum-low (hypoalbuminemia)  1  8/13 (61.54%)  3/10 (30.00%)  0/2 (0.00%)  2/3 (66.67%) 
Alkaline phosphatase increase  1  5/13 (38.46%)  6/10 (60.00%)  2/2 (100.00%)  2/3 (66.67%) 
ALT increase (serum glutamic pyruvic transaminase)  1  5/13 (38.46%)  2/10 (20.00%)  1/2 (50.00%)  2/3 (66.67%) 
AST increase (serum glutamic oxaloacetic transaminase)  1  8/13 (61.54%)  6/10 (60.00%)  2/2 (100.00%)  3/3 (100.00%) 
Bilirubin increase (hyperbilirubinemia)  1  6/13 (46.15%)  4/10 (40.00%)  1/2 (50.00%)  2/3 (66.67%) 
Creatinine increase  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Creatine phosphokinase (CPK)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Calcium, serum high (hypercalcemia)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Calcium, serum low (hypocalcemia)  1  7/13 (53.85%)  2/10 (20.00%)  0/2 (0.00%)  2/3 (66.67%) 
Glucose, serum high (hyperglycemia)  1  7/13 (53.85%)  4/10 (40.00%)  0/2 (0.00%)  0/3 (0.00%) 
Magnesium, serum low (hypomagnesemia)  1  10/13 (76.92%)  10/10 (100.00%)  2/2 (100.00%)  3/3 (100.00%) 
Phosphate, serum low (hypophosphatemia)  1  6/13 (46.15%)  3/10 (30.00%)  0/2 (0.00%)  3/3 (100.00%) 
Potassium, serum high (hyperkalemia)  1  1/13 (7.69%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Potassium, serum low (hypokalemia)  1  10/13 (76.92%)  6/10 (60.00%)  1/2 (50.00%)  3/3 (100.00%) 
Sodium, se high (hypernatremia)  1  3/13 (23.08%)  3/10 (30.00%)  0/2 (0.00%)  1/3 (33.33%) 
Sodium, serum low (hyponatremia)  1  4/13 (30.77%)  3/10 (30.00%)  2/2 (100.00%)  1/3 (33.33%) 
Depression  1  0/13 (0.00%)  0/10 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Neck stiffness  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle weakness generalized  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Muscle cramps  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Muscle spasms  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Abdomen pain  1  4/13 (30.77%)  4/10 (40.00%)  0/2 (0.00%)  1/3 (33.33%) 
Back pain  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Extremity/limb pain  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Nervous system disorders         
Sensory Neuropathy  1  0/13 (0.00%)  1/10 (10.00%)  1/2 (50.00%)  0/3 (0.00%) 
Confusion  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Dizziness  1  3/13 (23.08%)  1/10 (10.00%)  1/2 (50.00%)  1/3 (33.33%) 
Fainting (syncope episode)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders         
Urine color change  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Decreased GFR  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Reproductive system and breast disorders         
Erectile dysfunction  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Vaginal dryness  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pain in throat  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Cough  1  1/13 (7.69%)  2/10 (20.00%)  0/2 (0.00%)  1/3 (33.33%) 
Dyspnea (shortness of breath)  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Hiccoughs  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Voice changes/dysarthria  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Congestion  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Wheezing  1  0/13 (0.00%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders         
Cheilitis  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Hair loss (alopecia)  1  3/13 (23.08%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Hyperpigmentation  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Nail changes  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Pruritis  1  2/13 (15.38%)  2/10 (20.00%)  0/2 (0.00%)  0/3 (0.00%) 
Acne/acneiform  1  9/13 (69.23%)  10/10 (100.00%)  1/2 (50.00%)  2/3 (66.67%) 
Rash/desquamation  1  2/13 (15.38%)  1/10 (10.00%)  0/2 (0.00%)  0/3 (0.00%) 
Rash: Hand-foot skin reaction  1  2/13 (15.38%)  2/10 (20.00%)  0/2 (0.00%)  0/3 (0.00%) 
Dry skin  1  4/13 (30.77%)  0/10 (0.00%)  1/2 (50.00%)  0/3 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome  1  2/13 (15.38%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Paronychia  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Fungal infection beneath left breast  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Pseudomonas  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Extensive growth of eyelashes  1  1/13 (7.69%)  0/10 (0.00%)  0/2 (0.00%)  0/3 (0.00%) 
Scalp rash  1  0/13 (0.00%)  0/10 (0.00%)  1/2 (50.00%)  0/3 (0.00%) 
Face rash  1  0/13 (0.00%)  0/10 (0.00%)  1/2 (50.00%)  0/3 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Sponsor did not renew contract and only 28 patients of the anticipated 96 were enrolled and treated on the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Al Benson
Organization: Northwestern University
Phone: (312) 695-0184
EMail: albenson@nm.org
Layout table for additonal information
Responsible Party: Al Benson, Northwestern University
ClinicalTrials.gov Identifier: NCT00940316     History of Changes
Other Study ID Numbers: NU 07I4
STU00004101 ( Other Identifier: Northwestern University IRB )
OSI 4263s ( Other Identifier: OSI Pharmaceuticals, Inc )
First Submitted: July 15, 2009
First Posted: July 16, 2009
Results First Submitted: August 17, 2018
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019