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Trial record 18 of 166 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic 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: NCT02164916
Recruitment Status : Active, not recruiting
First Posted : June 17, 2014
Results First Posted : October 31, 2017
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Roche-Genentech
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: cetuximab
Drug: irinotecan hydrochloride
Drug: vemurafenib
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Cetuximab, Irinotecan Hydrochloride) Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)
Hide Arm/Group Description

Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

vemurafenib: Given PO

Period Title: Overall Study
Started 52 54
Eligible 50 49
Cross-over to Arm II 24 [1] 0
Completed 0 0
Not Completed 52 54
Reason Not Completed
Adverse Event             3             8
Death             1             1
Refusal unrelated to adverse event             3             7
Progression             37             26
Not protocol specified             5             1
Reason under review             1             6
Not eligible             2             5
[1]
Following disease progression on Arm 1. Note: these patients are also counted in 'Not Completed'.
Arm/Group Title Arm I (Cetuximab, Irinotecan Hydrochloride) Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib) Total
Hide Arm/Group Description

Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

vemurafenib: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 50 49 99
Hide Baseline Analysis Population Description
All eligible patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 49 participants 99 participants
62
(31 to 83)
60
(34 to 83)
62
(31 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
Female
37
  74.0%
21
  42.9%
58
  58.6%
Male
13
  26.0%
28
  57.1%
41
  41.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
Hispanic or Latino
2
   4.0%
2
   4.1%
4
   4.0%
Not Hispanic or Latino
48
  96.0%
46
  93.9%
94
  94.9%
Unknown or Not Reported
0
   0.0%
1
   2.0%
1
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.0%
4
   8.2%
5
   5.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   2.0%
1
   1.0%
White
49
  98.0%
43
  87.8%
92
  92.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.0%
1
   1.0%
Prior treatment with Irinotecan  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
Yes 19 20 39
No 31 29 60
1.Primary Outcome
Title Progression-free Survival
Hide Description From date of randomization to date of 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. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.
Time Frame Up to 3 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients.
Arm/Group Title Arm I (Cetuximab, Irinotecan Hydrochloride) Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)
Hide Arm/Group Description:

Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

vemurafenib: Given PO

Overall Number of Participants Analyzed 50 49
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.8 to 2.1)
4.3
(3.6 to 5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cetuximab, Irinotecan Hydrochloride), Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.31 to 0.75
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
Arm/Group Title Cetuximab + Irinotecan Vemurafenib + Cetuximab + Irinotecan Crossover: Vemurafenib + Cetuximab + Irinotecan
Hide Arm/Group Description:
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 46 46 21
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 1 2 0
Alkaline phosphatase increased 2 0 1
Allergic reaction 1 0 0
Anaphylaxis 1 0 0
Anemia 0 6 1
Anorexia 2 3 0
Arthralgia 0 3 0
Arthritis 0 0 1
Blood bilirubin increased 1 0 1
Cardiac disorders - Other, specify 0 0 1
Colitis 0 0 1
Colonic obstruction 1 0 0
Creatinine increased 0 1 0
Dehydration 3 5 0
Diarrhea 6 11 7
Electrocardiogram QT corrected interval prolonged 0 1 1
Fatigue 7 7 7
Febrile neutropenia 2 5 0
Gastric hemorrhage 0 0 1
Generalized muscle weakness 1 1 1
Hyperkalemia 0 0 1
Hypocalcemia 0 0 1
Hypokalemia 1 5 2
Hypomagnesemia 2 0 1
Hyponatremia 1 2 0
Infusion related reaction 1 1 0
Insomnia 0 0 1
Lower gastrointestinal hemorrhage 0 0 1
Lung infection 0 1 0
Lymphocyte count decreased 0 1 0
Metabolic acidosis 1 0 0
Mucositis oral 0 2 0
Myalgia 0 2 0
Nausea 1 9 1
Neutrophil count decreased 3 15 2
Pain 0 1 0
Palmar-plantar erythrodysesthesia syndrome 0 0 1
Pancreatitis 0 1 0
Papulopustular rash 1 0 0
Photosensitivity 0 1 0
Platelet count decreased 0 1 0
Pruritus 1 0 0
Rash acneiform 3 0 0
Rash maculo-papular 0 1 1
Rash pustular 0 1 0
Sepsis 0 2 0
Thromboembolic event 0 0 1
Treatment related secondary malignancy 0 0 1
Urinary tract infection 1 0 1
Vomiting 1 5 0
Weight loss 1 0 0
White blood cell decreased 0 8 2
3.Other Pre-specified Outcome
Title Overall Survival
Hide Description From date of randomization 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 3 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients
Arm/Group Title Arm I (Cetuximab, Irinotecan Hydrochloride) Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)
Hide Arm/Group Description:

Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

vemurafenib: Given PO

Overall Number of Participants Analyzed 50 49
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(3.0 to 9.9)
9.6
(7.5 to 13.1)
4.Other Pre-specified Outcome
Title Overall Response Rate
Hide Description Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time Frame Up to 3 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and analyzable patients with measurable disease.
Arm/Group Title Arm I (Cetuximab, Irinotecan Hydrochloride) Arm II (Cetuximab, Irinotecan Hydrochloride, Vemurafenib)
Hide Arm/Group Description:

Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm II.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

Patients receive cetuximab and irinotecan hydrochloride as in Arm I and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

irinotecan hydrochloride: Given IV

vemurafenib: Given PO

Overall Number of Participants Analyzed 47 44
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
   2.1%
3
   6.8%
Unconfirmed Partial Response
1
   2.1%
4
   9.1%
Stable/No Response
8
  17.0%
22
  50.0%
Increasing Disease
25
  53.2%
7
  15.9%
Symptomatic Deterioration
6
  12.8%
1
   2.3%
Assessment Inadequate
6
  12.8%
7
  15.9%
5.Other Pre-specified Outcome
Title Progression-free Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1
Hide Description From date of Step 3 Crossover registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.
Time Frame Up to 3 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible and analyzable patients.
Arm/Group Title Crossover: Vemurafenib + Cetuximab + Irinotecan
Hide Arm/Group Description:
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(2.8 to 6.1)
6.Other Pre-specified Outcome
Title Overall Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1
Hide Description From date of randomization 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 3 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients
Arm/Group Title Crossover: Vemurafenib + Cetuximab + Irinotecan
Hide Arm/Group Description:
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
12.1
(4.5 to 12.5)
7.Other Pre-specified Outcome
Title Overall Response Rate in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1
Hide Description Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time Frame Up to 3 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable patients with measurable disease.
Arm/Group Title Crossover: Vemurafenib + Cetuximab + Irinotecan
Hide Arm/Group Description:
Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
2
  11.1%
Unconfirmed Partial Response
1
   5.6%
Stable/No Response
10
  55.6%
Increasing Disease
5
  27.8%
Time Frame Up to 3 years
Adverse Event Reporting Description Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
 
Arm/Group Title Cetuximab + Irinotecan Vemurafenib + Cetuximab + Irinotecan Crossover: Vemurafenib + Cetuximab + Irinotecan
Hide Arm/Group Description Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive cetuximab IV and irinotecan hydrochloride IV on days 1 and 14, and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Cetuximab + Irinotecan Vemurafenib + Cetuximab + Irinotecan Crossover: Vemurafenib + Cetuximab + Irinotecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/46 (6.52%)   4/46 (8.70%)   2/21 (9.52%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cetuximab + Irinotecan Vemurafenib + Cetuximab + Irinotecan Crossover: Vemurafenib + Cetuximab + Irinotecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/46 (6.52%)   25/46 (54.35%)   10/21 (47.62%) 
Blood and lymphatic system disorders       
Anemia  1  0/46 (0.00%)  4/46 (8.70%)  0/21 (0.00%) 
Febrile neutropenia  1  1/46 (2.17%)  4/46 (8.70%)  0/21 (0.00%) 
Cardiac disorders       
Atrial flutter  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Cardiac disorders-Other  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Pericardial effusion  1  1/46 (2.17%)  0/46 (0.00%)  0/21 (0.00%) 
Sinus tachycardia  1  1/46 (2.17%)  0/46 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/46 (0.00%)  4/46 (8.70%)  1/21 (4.76%) 
Ascites  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Colitis  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Colonic obstruction  1  1/46 (2.17%)  0/46 (0.00%)  1/21 (4.76%) 
Colonic perforation  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Constipation  1  0/46 (0.00%)  1/46 (2.17%)  1/21 (4.76%) 
Diarrhea  1  0/46 (0.00%)  5/46 (10.87%)  0/21 (0.00%) 
Duodenal hemorrhage  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Hemorrhoidal hemorrhage  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Jejunal obstruction  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Lower gastrointestinal hemorrhage  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Nausea  1  0/46 (0.00%)  5/46 (10.87%)  1/21 (4.76%) 
Pancreatitis  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Rectal hemorrhage  1  0/46 (0.00%)  1/46 (2.17%)  1/21 (4.76%) 
Small intestinal obstruction  1  0/46 (0.00%)  5/46 (10.87%)  0/21 (0.00%) 
Vomiting  1  0/46 (0.00%)  4/46 (8.70%)  1/21 (4.76%) 
General disorders       
Death NOS  1  1/46 (2.17%)  0/46 (0.00%)  1/21 (4.76%) 
Fatigue  1  0/46 (0.00%)  3/46 (6.52%)  1/21 (4.76%) 
Fever  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Infections and infestations       
Lung infection  1  0/46 (0.00%)  2/46 (4.35%)  1/21 (4.76%) 
Sepsis  1  0/46 (0.00%)  4/46 (8.70%)  0/21 (0.00%) 
Urinary tract infection  1  0/46 (0.00%)  2/46 (4.35%)  1/21 (4.76%) 
Investigations       
Alanine aminotransferase increased  1  0/46 (0.00%)  1/46 (2.17%)  2/21 (9.52%) 
Alkaline phosphatase increased  1  0/46 (0.00%)  2/46 (4.35%)  2/21 (9.52%) 
Aspartate aminotransferase increased  1  0/46 (0.00%)  1/46 (2.17%)  2/21 (9.52%) 
Blood bilirubin increased  1  1/46 (2.17%)  1/46 (2.17%)  2/21 (9.52%) 
Electrocardiogram QT corrected interval prolonged  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Neutrophil count decreased  1  0/46 (0.00%)  3/46 (6.52%)  0/21 (0.00%) 
White blood cell decreased  1  0/46 (0.00%)  2/46 (4.35%)  0/21 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  0/46 (0.00%)  2/46 (4.35%)  0/21 (0.00%) 
Dehydration  1  0/46 (0.00%)  5/46 (10.87%)  0/21 (0.00%) 
Hyponatremia  1  0/46 (0.00%)  2/46 (4.35%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified - Other  1  2/46 (4.35%)  2/46 (4.35%)  1/21 (4.76%) 
Treatment related secondary malignancy  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Renal and urinary disorders       
Acute kidney injury  1  1/46 (2.17%)  1/46 (2.17%)  0/21 (0.00%) 
Renal calculi  1  0/46 (0.00%)  0/46 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Pleural effusion  1  0/46 (0.00%)  1/46 (2.17%)  1/21 (4.76%) 
Respiratory failure  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin and subcutaneous tissue disorders - Other  1  0/46 (0.00%)  1/46 (2.17%)  0/21 (0.00%) 
Vascular disorders       
Thromboembolic event  1  1/46 (2.17%)  1/46 (2.17%)  1/21 (4.76%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab + Irinotecan Vemurafenib + Cetuximab + Irinotecan Crossover: Vemurafenib + Cetuximab + Irinotecan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/46 (97.83%)   41/46 (89.13%)   21/21 (100.00%) 
Blood and lymphatic system disorders       
Anemia  1  11/46 (23.91%)  21/46 (45.65%)  9/21 (42.86%) 
Eye disorders       
Blurred vision  1  1/46 (2.17%)  4/46 (8.70%)  1/21 (4.76%) 
Conjunctivitis  1  1/46 (2.17%)  0/46 (0.00%)  2/21 (9.52%) 
Eye disorders-Other  1  1/46 (2.17%)  3/46 (6.52%)  1/21 (4.76%) 
Gastrointestinal disorders       
Abdominal distension  1  2/46 (4.35%)  0/46 (0.00%)  2/21 (9.52%) 
Abdominal pain  1  19/46 (41.30%)  18/46 (39.13%)  5/21 (23.81%) 
Colonic obstruction  1  3/46 (6.52%)  0/46 (0.00%)  1/21 (4.76%) 
Constipation  1  11/46 (23.91%)  3/46 (6.52%)  4/21 (19.05%) 
Diarrhea  1  27/46 (58.70%)  28/46 (60.87%)  16/21 (76.19%) 
Dyspepsia  1  2/46 (4.35%)  3/46 (6.52%)  1/21 (4.76%) 
Hemorrhoids  1  3/46 (6.52%)  1/46 (2.17%)  0/21 (0.00%) 
Mucositis oral  1  7/46 (15.22%)  19/46 (41.30%)  5/21 (23.81%) 
Nausea  1  27/46 (58.70%)  27/46 (58.70%)  16/21 (76.19%) 
Vomiting  1  14/46 (30.43%)  21/46 (45.65%)  6/21 (28.57%) 
General disorders       
Edema limbs  1  3/46 (6.52%)  8/46 (17.39%)  4/21 (19.05%) 
Fatigue  1  31/46 (67.39%)  32/46 (69.57%)  16/21 (76.19%) 
Fever  1  2/46 (4.35%)  9/46 (19.57%)  2/21 (9.52%) 
Infusion related reaction  1  4/46 (8.70%)  3/46 (6.52%)  1/21 (4.76%) 
Pain  1  3/46 (6.52%)  4/46 (8.70%)  4/21 (19.05%) 
Infections and infestations       
Urinary tract infection  1  2/46 (4.35%)  0/46 (0.00%)  2/21 (9.52%) 
Injury, poisoning and procedural complications       
Bruising  1  0/46 (0.00%)  3/46 (6.52%)  1/21 (4.76%) 
Fall  1  3/46 (6.52%)  0/46 (0.00%)  1/21 (4.76%) 
Investigations       
Alanine aminotransferase increased  1  10/46 (21.74%)  3/46 (6.52%)  4/21 (19.05%) 
Alkaline phosphatase increased  1  11/46 (23.91%)  7/46 (15.22%)  7/21 (33.33%) 
Aspartate aminotransferase increased  1  12/46 (26.09%)  4/46 (8.70%)  5/21 (23.81%) 
Blood bilirubin increased  1  3/46 (6.52%)  7/46 (15.22%)  2/21 (9.52%) 
Creatinine increased  1  1/46 (2.17%)  4/46 (8.70%)  0/21 (0.00%) 
INR increased  1  0/46 (0.00%)  0/46 (0.00%)  2/21 (9.52%) 
Lymphocyte count decreased  1  1/46 (2.17%)  4/46 (8.70%)  3/21 (14.29%) 
Neutrophil count decreased  1  11/46 (23.91%)  20/46 (43.48%)  8/21 (38.10%) 
Platelet count decreased  1  5/46 (10.87%)  3/46 (6.52%)  0/21 (0.00%) 
Weight loss  1  6/46 (13.04%)  13/46 (28.26%)  3/21 (14.29%) 
White blood cell decreased  1  8/46 (17.39%)  15/46 (32.61%)  5/21 (23.81%) 
Metabolism and nutrition disorders       
Anorexia  1  13/46 (28.26%)  14/46 (30.43%)  5/21 (23.81%) 
Dehydration  1  10/46 (21.74%)  2/46 (4.35%)  5/21 (23.81%) 
Hyperglycemia  1  6/46 (13.04%)  5/46 (10.87%)  4/21 (19.05%) 
Hypoalbuminemia  1  11/46 (23.91%)  8/46 (17.39%)  7/21 (33.33%) 
Hypocalcemia  1  4/46 (8.70%)  4/46 (8.70%)  1/21 (4.76%) 
Hypokalemia  1  12/46 (26.09%)  20/46 (43.48%)  6/21 (28.57%) 
Hypomagnesemia  1  20/46 (43.48%)  12/46 (26.09%)  11/21 (52.38%) 
Hyponatremia  1  5/46 (10.87%)  10/46 (21.74%)  4/21 (19.05%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/46 (4.35%)  14/46 (30.43%)  7/21 (33.33%) 
Back pain  1  4/46 (8.70%)  1/46 (2.17%)  1/21 (4.76%) 
Generalized muscle weakness  1  4/46 (8.70%)  2/46 (4.35%)  2/21 (9.52%) 
Musculoskeletal and connective tiss disorder - Other  1  1/46 (2.17%)  0/46 (0.00%)  3/21 (14.29%) 
Myalgia  1  0/46 (0.00%)  7/46 (15.22%)  4/21 (19.05%) 
Pain in extremity  1  0/46 (0.00%)  9/46 (19.57%)  2/21 (9.52%) 
Nervous system disorders       
Dizziness  1  4/46 (8.70%)  6/46 (13.04%)  2/21 (9.52%) 
Dysgeusia  1  2/46 (4.35%)  4/46 (8.70%)  2/21 (9.52%) 
Headache  1  5/46 (10.87%)  5/46 (10.87%)  1/21 (4.76%) 
Peripheral sensory neuropathy  1  4/46 (8.70%)  9/46 (19.57%)  3/21 (14.29%) 
Psychiatric disorders       
Anxiety  1  2/46 (4.35%)  3/46 (6.52%)  1/21 (4.76%) 
Depression  1  1/46 (2.17%)  5/46 (10.87%)  0/21 (0.00%) 
Insomnia  1  5/46 (10.87%)  4/46 (8.70%)  2/21 (9.52%) 
Renal and urinary disorders       
Hematuria  1  2/46 (4.35%)  1/46 (2.17%)  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/46 (4.35%)  4/46 (8.70%)  0/21 (0.00%) 
Dyspnea  1  8/46 (17.39%)  7/46 (15.22%)  4/21 (19.05%) 
Pleural effusion  1  1/46 (2.17%)  1/46 (2.17%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  5/46 (10.87%)  15/46 (32.61%)  4/21 (19.05%) 
Dry skin  1  9/46 (19.57%)  8/46 (17.39%)  3/21 (14.29%) 
Palmar-plantar erythrodysesthesia syndrome  1  1/46 (2.17%)  3/46 (6.52%)  3/21 (14.29%) 
Photosensitivity  1  0/46 (0.00%)  11/46 (23.91%)  4/21 (19.05%) 
Pruritus  1  4/46 (8.70%)  4/46 (8.70%)  1/21 (4.76%) 
Rash acneiform  1  27/46 (58.70%)  22/46 (47.83%)  10/21 (47.62%) 
Rash maculo-papular  1  6/46 (13.04%)  13/46 (28.26%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders - Other  1  1/46 (2.17%)  8/46 (17.39%)  2/21 (9.52%) 
Skin hyperpigmentation  1  1/46 (2.17%)  1/46 (2.17%)  2/21 (9.52%) 
Vascular disorders       
Hot flashes  1  0/46 (0.00%)  3/46 (6.52%)  1/21 (4.76%) 
Hypertension  1  4/46 (8.70%)  5/46 (10.87%)  1/21 (4.76%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: SWOG Statistician
Organization: SWOG Statistics & Data Management Center
Phone: 206-667-4408
EMail: smcdonou@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02164916     History of Changes
Other Study ID Numbers: S1406
U10CA180888 ( U.S. NIH Grant/Contract )
S1406 ( Other Identifier: SWOG )
NCI-2014-00814 ( Other Identifier: NCI )
First Submitted: June 13, 2014
First Posted: June 17, 2014
Results First Submitted: July 13, 2017
Results First Posted: October 31, 2017
Last Update Posted: August 20, 2019