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Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

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: NCT00499369
Recruitment Status : Terminated (Due to inadequate accrual, study was terminated and limited outcome data was reported.)
First Posted : July 11, 2007
Results First Posted : January 15, 2014
Last Update Posted : July 31, 2014
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Biological: bevacizumab
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Hide Arm/Group Description Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Period Title: Overall Study
Started 16 18 17 9 12
Eligible 14 16 16 8 12
Completed 0 0 0 0 0
Not Completed 16 18 17 9 12
Reason Not Completed
Adverse Event             2             2             3             1             2
Withdrawal by Subject             0             1             1             0             0
Progression             10             12             9             6             10
Death             0             1             0             0             0
Not protocol specified             2             0             3             1             0
Ineligible             2             2             1             1             0
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab Total
Hide Arm/Group Description Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Total of all reporting groups
Overall Number of Baseline Participants 14 16 16 8 12 66
Hide Baseline Analysis Population Description
All eligible patients are included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
60
(44 to 76)
63
(37 to 77)
58
(46 to 75)
65
(47 to 73)
59
(38 to 70)
60
(37 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
Female
6
  42.9%
8
  50.0%
5
  31.3%
2
  25.0%
7
  58.3%
28
  42.4%
Male
8
  57.1%
8
  50.0%
11
  68.8%
6
  75.0%
5
  41.7%
38
  57.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
Hispanic or Latino
2
  14.3%
3
  18.8%
2
  12.5%
2
  25.0%
2
  16.7%
11
  16.7%
Not Hispanic or Latino
12
  85.7%
13
  81.3%
12
  75.0%
6
  75.0%
9
  75.0%
52
  78.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
  12.5%
0
   0.0%
1
   8.3%
3
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
1
   1.5%
Asian
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
1
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.1%
2
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
3
   4.5%
White
11
  78.6%
12
  75.0%
12
  75.0%
7
  87.5%
11
  91.7%
53
  80.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  14.3%
2
  12.5%
2
  12.5%
1
  12.5%
1
   8.3%
8
  12.1%
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
0 9 8 8 1 4 30
>= 1 5 8 8 7 8 36
[1]
Measure Description: Patients graded according to the Zubrod Performance Status Scale: 0 is fully active, able to carry on all pre-disease performance without restriction; 1 is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 is ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours; 3 is capable of limited self-care, confined to bed or chair more than 50% of waking hours; and 4 is completely disabled, cannot carry on any self-care, totally confined to bed or chair.
Discontinuation of oxaliplatin while on first-line treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
Discontinued 5 9 8 4 9 35
Did not discontinue 9 7 8 4 3 31
Planned concurrent chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
FOLFIRI 10 11 12 5 8 46
Single-agent irinotecan 4 5 4 3 4 20
Time from last dose of bevacizumab  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 16 participants 8 participants 12 participants 66 participants
14-42 days 12 13 13 6 8 52
43 days or higher 2 3 3 2 4 14
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients are included in this analysis.
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Hide Arm/Group Description:
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Overall Number of Participants Analyzed 14 16 16 8 12
Median (95% Confidence Interval)
Unit of Measure: months
3.2
(1.4 to 3.8)
4.2
(2.2 to 6.7)
8.5
(2.2 to 9.4)
1.4
(1.2 to 4.4)
5.6
(3.4 to 6.9)
2.Secondary Outcome
Title Overall Survival
Hide Description Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to limited accrual.
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Hide Arm/Group Description:
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Objective Tumor Response
Hide Description [Not Specified]
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to limited accrual.
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Hide Arm/Group Description:
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity
Hide Description Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Hide Arm/Group Description:
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
Overall Number of Participants Analyzed 14 16 16 7 12
Measure Type: Number
Unit of Measure: Participants
Albumin, serum-low (hypoalbuminemia) 1 0 0 0 0
Alkaline phosphatase 0 0 1 1 0
Anorexia 0 1 0 0 1
Bilirubin (hyperbilirubinemia) 1 0 0 0 1
Colitis, infectious (e.g., Clostridium difficile) 0 0 1 0 0
Confusion 1 0 0 0 0
Constipation 0 0 0 0 1
Cough 0 0 0 0 1
Dehydration 2 0 2 0 1
Diarrhea 3 2 3 3 5
Dyspnea (shortness of breath) 0 1 0 0 0
Edema: limb 0 0 1 0 0
Edema: trunk/genital 0 0 1 0 0
Encephalopathy 1 0 0 0 0
Fatigue (asthenia, lethargy, malaise) 0 1 3 0 2
Febrile neutropenia 2 2 1 0 0
Hemoglobin 1 1 0 1 1
Hemorrhage, GI - Stoma 0 0 0 0 1
Hypertension 0 0 0 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS 1 0 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 1 0 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1 0 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS 0 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 1 0 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa 0 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 0 1 0 0 1
Leukocytes (total WBC) 5 4 2 2 0
Lymphopenia 0 0 1 0 0
Magnesium, serum-low (hypomagnesemia) 0 0 1 0 0
Mental status 1 0 0 0 0
Mucositis/stomatitis (clinical exam) - Oral cavity 0 1 1 0 0
Mucositis/stomatitis (functional/symp) - Oral cav 0 0 1 0 0
Mucositis/stomatitis (functional/symp) - Pharynx 0 0 0 0 1
Nasal cavity/paranasal sinus reactions 0 0 0 0 1
Nausea 0 1 3 0 0
Neuropathy: sensory 0 0 0 1 0
Neutrophils/granulocytes (ANC/AGC) 4 7 7 3 3
Pain - Pain NOS 0 0 0 0 1
Phosphate, serum-low (hypophosphatemia) 0 0 0 1 0
Platelets 1 2 0 0 0
Pneumonitis/pulmonary infiltrates 1 0 0 0 0
Potassium, serum-low (hypokalemia) 0 2 0 1 0
Rash/desquamation 0 1 1 0 0
Rash: acne/acneiform 3 2 4 2 0
Rash: hand-foot skin reaction 0 0 1 0 0
Sodium, serum-low (hyponatremia) 0 0 0 0 1
Thrombosis/thrombus/embolism 0 0 0 1 0
Vomiting 0 0 1 0 1
Time Frame Up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Hide Arm/Group Description Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen) Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
All-Cause Mortality
Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/14 (21.43%)   7/16 (43.75%)   3/16 (18.75%)   3/7 (42.86%)   0/12 (0.00%) 
Blood and lymphatic system disorders           
Febrile neutropenia  1  1/14 (7.14%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders           
Diarrhea  1  0/14 (0.00%)  0/16 (0.00%)  2/16 (12.50%)  2/7 (28.57%)  0/12 (0.00%) 
Obstruction, GI - Ileum  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Obstruction, GI - Small bowel NOS  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Pain - Abdomen NOS  1  0/14 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  1/7 (14.29%)  0/12 (0.00%) 
General disorders           
Fatigue (asthenia, lethargy, malaise)  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Infections and infestations           
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Infection-Other (Specify)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Investigations           
Leukocytes (total WBC)  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/14 (7.14%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders           
Albumin, serum-low (hypoalbuminemia)  1  0/14 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Dehydration  1  0/14 (0.00%)  1/16 (6.25%)  2/16 (12.50%)  0/7 (0.00%)  0/12 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Sodium, serum-low (hyponatremia)  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Death - Disease progression NOS  1  1/14 (7.14%)  5/16 (31.25%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Renal and urinary disorders           
Obstruction, GU - Bladder  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Urinary retention (including neurogenic bladder)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pneumonitis/pulmonary infiltrates  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Vascular disorders           
Hypotension  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort I: Chemotherapy + Cetuximab Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab Cohort II: Chemotherapy + Cetuximab Cohort II: Chemotherapy + Bevacizumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/14 (100.00%)   16/16 (100.00%)   15/16 (93.75%)   7/7 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders           
Blood/Bone Marrow-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Febrile neutropenia  1  1/14 (7.14%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Hemoglobin  1  11/14 (78.57%)  7/16 (43.75%)  9/16 (56.25%)  6/7 (85.71%)  10/12 (83.33%) 
Cardiac disorders           
Pericardial effusion (non-malignant)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
SVT and nodal arrhythmia - SVT arrhythmia NOS  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
SVT and nodal arrhythmia - Sinus bradycardia  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Ventricular arrhythmia - Ventricular tachycardia  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Ear and labyrinth disorders           
Auditory/Ear-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Pain - External ear  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Eye disorders           
Dry eye syndrome  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Ocular/Visual-Other (Specify)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Ophthalmoplegia/diplopia (double vision)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Vision-blurred vision  1  1/14 (7.14%)  2/16 (12.50%)  2/16 (12.50%)  1/7 (14.29%)  0/12 (0.00%) 
Watery eye (epiphora, tearing)  1  1/14 (7.14%)  3/16 (18.75%)  2/16 (12.50%)  1/7 (14.29%)  0/12 (0.00%) 
Gastrointestinal disorders           
Constipation  1  5/14 (35.71%)  4/16 (25.00%)  9/16 (56.25%)  6/7 (85.71%)  4/12 (33.33%) 
Diarrhea  1  8/14 (57.14%)  13/16 (81.25%)  11/16 (68.75%)  3/7 (42.86%)  10/12 (83.33%) 
Distention/bloating, abdominal  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Dysphagia (difficulty swallowing)  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  2/12 (16.67%) 
Fistula, GI - Abdomen NOS  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Gastrointestinal-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Heartburn/dyspepsia  1  0/14 (0.00%)  0/16 (0.00%)  3/16 (18.75%)  2/7 (28.57%)  1/12 (8.33%) 
Hemorrhage, GI - Lower GI NOS  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Hemorrhage, GI - Oral cavity  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  1/12 (8.33%) 
Hemorrhage, GI - Rectum  1  0/14 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Hemorrhage, GI - Upper GI NOS  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Hemorrhoids  1  1/14 (7.14%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Incontinence, anal  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  1/12 (8.33%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  3/14 (21.43%)  6/16 (37.50%)  7/16 (43.75%)  2/7 (28.57%)  2/12 (16.67%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  3/14 (21.43%)  3/16 (18.75%)  8/16 (50.00%)  3/7 (42.86%)  4/12 (33.33%) 
Nausea  1  8/14 (57.14%)  6/16 (37.50%)  13/16 (81.25%)  3/7 (42.86%)  9/12 (75.00%) 
Obstruction, GI - Small bowel NOS  1  1/14 (7.14%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Pain - Abdomen NOS  1  3/14 (21.43%)  6/16 (37.50%)  8/16 (50.00%)  2/7 (28.57%)  6/12 (50.00%) 
Pain - Anus  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain - Rectum  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  1/12 (8.33%) 
Vomiting  1  4/14 (28.57%)  7/16 (43.75%)  8/16 (50.00%)  1/7 (14.29%)  8/12 (66.67%) 
General disorders           
Constitutional Symptoms-Other (Specify)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Edema: limb  1  4/14 (28.57%)  0/16 (0.00%)  3/16 (18.75%)  1/7 (14.29%)  2/12 (16.67%) 
Edema: trunk/genital  1  0/14 (0.00%)  0/16 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/12 (0.00%) 
Fatigue (asthenia, lethargy, malaise)  1  8/14 (57.14%)  10/16 (62.50%)  13/16 (81.25%)  6/7 (85.71%)  10/12 (83.33%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  2/14 (14.29%)  1/16 (6.25%)  1/16 (6.25%)  1/7 (14.29%)  1/12 (8.33%) 
Flu-like syndrome  1  1/14 (7.14%)  1/16 (6.25%)  1/16 (6.25%)  1/7 (14.29%)  0/12 (0.00%) 
Injection site reaction/extravasation changes  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Pain - Chest/thorax NOS  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain - Pain NOS  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Rigors/chills  1  2/14 (14.29%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/12 (8.33%) 
Hepatobiliary disorders           
Pain - Liver  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Immune system disorders           
Allergic reaction/hypersensitivity  1  1/14 (7.14%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Infections and infestations           
Colitis, infectious (e.g., Clostridium difficile)  1  0/14 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - UTI  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Muscle  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Pharynx  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  1/7 (14.29%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Ungual  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Infection with unknown ANC - Conjunctiva  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Infection with unknown ANC - Skin (cellulitis)  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Infection with unknown ANC - Upper airway NOS  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Infection-Other (Specify)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications           
Hemorrhage, GI - Stoma  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Thrombosis/embolism (vascular access-related)  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Investigations           
ALT, SGPT (serum glutamic pyruvic transaminase)  1  2/14 (14.29%)  3/16 (18.75%)  3/16 (18.75%)  2/7 (28.57%)  2/12 (16.67%) 
AST, SGOT  1  2/14 (14.29%)  6/16 (37.50%)  7/16 (43.75%)  2/7 (28.57%)  7/12 (58.33%) 
Alkaline phosphatase  1  6/14 (42.86%)  8/16 (50.00%)  6/16 (37.50%)  4/7 (57.14%)  7/12 (58.33%) 
Bilirubin (hyperbilirubinemia)  1  3/14 (21.43%)  2/16 (12.50%)  3/16 (18.75%)  0/7 (0.00%)  3/12 (25.00%) 
Creatinine  1  2/14 (14.29%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  4/12 (33.33%) 
INR (of prothrombin time)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Leukocytes (total WBC)  1  10/14 (71.43%)  9/16 (56.25%)  9/16 (56.25%)  3/7 (42.86%)  7/12 (58.33%) 
Lymphopenia  1  1/14 (7.14%)  1/16 (6.25%)  1/16 (6.25%)  1/7 (14.29%)  2/12 (16.67%) 
Metabolic/Laboratory-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  3/12 (25.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  8/14 (57.14%)  8/16 (50.00%)  12/16 (75.00%)  3/7 (42.86%)  7/12 (58.33%) 
Platelets  1  2/14 (14.29%)  5/16 (31.25%)  4/16 (25.00%)  0/7 (0.00%)  6/12 (50.00%) 
Weight loss  1  1/14 (7.14%)  3/16 (18.75%)  5/16 (31.25%)  3/7 (42.86%)  3/12 (25.00%) 
Metabolism and nutrition disorders           
Albumin, serum-low (hypoalbuminemia)  1  4/14 (28.57%)  8/16 (50.00%)  4/16 (25.00%)  3/7 (42.86%)  6/12 (50.00%) 
Anorexia  1  3/14 (21.43%)  4/16 (25.00%)  8/16 (50.00%)  2/7 (28.57%)  8/12 (66.67%) 
Bicarbonate, serum-low  1  1/14 (7.14%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Calcium, serum-low (hypocalcemia)  1  4/14 (28.57%)  4/16 (25.00%)  5/16 (31.25%)  3/7 (42.86%)  6/12 (50.00%) 
Dehydration  1  3/14 (21.43%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  5/12 (41.67%) 
Glucose, serum-high (hyperglycemia)  1  5/14 (35.71%)  4/16 (25.00%)  8/16 (50.00%)  3/7 (42.86%)  8/12 (66.67%) 
Glucose, serum-low (hypoglycemia)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  1/12 (8.33%) 
Magnesium, serum-high (hypermagnesemia)  1  0/14 (0.00%)  0/16 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/12 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  6/14 (42.86%)  6/16 (37.50%)  9/16 (56.25%)  3/7 (42.86%)  5/12 (41.67%) 
Phosphate, serum-low (hypophosphatemia)  1  1/14 (7.14%)  1/16 (6.25%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  1/14 (7.14%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Potassium, serum-low (hypokalemia)  1  3/14 (21.43%)  6/16 (37.50%)  6/16 (37.50%)  4/7 (57.14%)  5/12 (41.67%) 
Sodium, serum-high (hypernatremia)  1  1/14 (7.14%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Sodium, serum-low (hyponatremia)  1  2/14 (14.29%)  1/16 (6.25%)  3/16 (18.75%)  3/7 (42.86%)  7/12 (58.33%) 
Musculoskeletal and connective tissue disorders           
Joint-function  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Muscle weakness, not d/t neuropathy - body/general  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  2/12 (16.67%) 
Pain - Back  1  1/14 (7.14%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain - Extremity-limb  1  0/14 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  1/7 (14.29%)  1/12 (8.33%) 
Pain - Joint  1  0/14 (0.00%)  2/16 (12.50%)  0/16 (0.00%)  1/7 (14.29%)  2/12 (16.67%) 
Pain - Muscle  1  1/14 (7.14%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  5/12 (41.67%) 
Nervous system disorders           
Ataxia (incoordination)  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Cognitive disturbance  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Dizziness  1  0/14 (0.00%)  2/16 (12.50%)  3/16 (18.75%)  1/7 (14.29%)  3/12 (25.00%) 
Encephalopathy  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Mental status  1  1/14 (7.14%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Neuropathy: motor  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/12 (8.33%) 
Neuropathy: sensory  1  2/14 (14.29%)  7/16 (43.75%)  5/16 (31.25%)  4/7 (57.14%)  6/12 (50.00%) 
Ocular/Visual-Other (Specify)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain - Head/headache  1  0/14 (0.00%)  1/16 (6.25%)  2/16 (12.50%)  0/7 (0.00%)  2/12 (16.67%) 
Pain - Neuralgia/peripheral nerve  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Taste alteration (dysgeusia)  1  1/14 (7.14%)  1/16 (6.25%)  1/16 (6.25%)  2/7 (28.57%)  2/12 (16.67%) 
Psychiatric disorders           
Confusion  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Insomnia  1  2/14 (14.29%)  1/16 (6.25%)  1/16 (6.25%)  2/7 (28.57%)  3/12 (25.00%) 
Mood alteration - anxiety  1  1/14 (7.14%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Mood alteration - depression  1  1/14 (7.14%)  0/16 (0.00%)  2/16 (12.50%)  2/7 (28.57%)  1/12 (8.33%) 
Renal and urinary disorders           
Hemorrhage, GU - Urinary NOS  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Pain - Bladder  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Proteinuria  1  1/14 (7.14%)  5/16 (31.25%)  4/16 (25.00%)  0/7 (0.00%)  5/12 (41.67%) 
Urinary frequency/urgency  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  1/12 (8.33%) 
Urine color change  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Reproductive system and breast disorders           
Hemorrhage, GU - Vagina  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Allergic rhinitis  1  0/14 (0.00%)  0/16 (0.00%)  3/16 (18.75%)  0/7 (0.00%)  1/12 (8.33%) 
Cough  1  1/14 (7.14%)  4/16 (25.00%)  4/16 (25.00%)  1/7 (14.29%)  2/12 (16.67%) 
Dyspnea (shortness of breath)  1  0/14 (0.00%)  2/16 (12.50%)  3/16 (18.75%)  1/7 (14.29%)  1/12 (8.33%) 
Hemorrhage, pulmonary/upper respiratory - Lung  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  1/14 (7.14%)  5/16 (31.25%)  3/16 (18.75%)  2/7 (28.57%)  5/12 (41.67%) 
Hiccoughs (hiccups, singultus)  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  1/12 (8.33%) 
Mucositis/stomatitis (functional/symp) - Pharynx  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Nasal cavity/paranasal sinus reactions  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  3/12 (25.00%) 
Pain - Throat/pharynx/larynx  1  0/14 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Pulmonary/Upper Respiratory-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  0/7 (0.00%)  1/12 (8.33%) 
Voice changes/dysarthria  1  1/14 (7.14%)  0/16 (0.00%)  2/16 (12.50%)  0/7 (0.00%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatology/Skin-Other (Specify)  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Dry skin  1  3/14 (21.43%)  7/16 (43.75%)  4/16 (25.00%)  3/7 (42.86%)  1/12 (8.33%) 
Hair loss/Alopecia (scalp or body)  1  4/14 (28.57%)  4/16 (25.00%)  5/16 (31.25%)  3/7 (42.86%)  7/12 (58.33%) 
Nail changes  1  3/14 (21.43%)  1/16 (6.25%)  1/16 (6.25%)  3/7 (42.86%)  0/12 (0.00%) 
Pain - Skin  1  0/14 (0.00%)  2/16 (12.50%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Petechiae/purpura (hemorrhage into skin or mucosa)  1  1/14 (7.14%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Photosensitivity  1  1/14 (7.14%)  1/16 (6.25%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Pruritus/itching  1  0/14 (0.00%)  0/16 (0.00%)  3/16 (18.75%)  1/7 (14.29%)  0/12 (0.00%) 
Rash/desquamation  1  2/14 (14.29%)  3/16 (18.75%)  6/16 (37.50%)  1/7 (14.29%)  0/12 (0.00%) 
Rash: acne/acneiform  1  10/14 (71.43%)  13/16 (81.25%)  13/16 (81.25%)  6/7 (85.71%)  1/12 (8.33%) 
Rash: hand-foot skin reaction  1  0/14 (0.00%)  2/16 (12.50%)  3/16 (18.75%)  1/7 (14.29%)  0/12 (0.00%) 
Sweating (diaphoresis)  1  0/14 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/7 (0.00%)  0/12 (0.00%) 
Vascular disorders           
Hemorrhage/Bleeding-Other (Specify)  1  1/14 (7.14%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  0/12 (0.00%) 
Hot flashes/flushes  1  1/14 (7.14%)  0/16 (0.00%)  0/16 (0.00%)  1/7 (14.29%)  0/12 (0.00%) 
Hypertension  1  0/14 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/7 (0.00%)  3/12 (25.00%) 
Thrombosis/thrombus/embolism  1  0/14 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  2/7 (28.57%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Due to inadequate accrual, study was terminated and limited outcome data was reported.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: SWOG
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00499369     History of Changes
Other Study ID Numbers: NCI-2009-00784
NCI-2009-00784 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB-SWOG-S0600
SWOG-S0600
CDR0000551934
ECOG-SWOG-S0600
CAN-NCIC-SWOG-S0600
NCCTG-SWOG-S0600
S0600 ( Other Identifier: Southwest Oncology Group )
S0600 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2007
First Posted: July 11, 2007
Results First Submitted: October 22, 2013
Results First Posted: January 15, 2014
Last Update Posted: July 31, 2014