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Trial record 69 of 168 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

Cetuximab, Bevacizumab & 5FU/Leucovorin vs. Oxaliplatin, Bevacizumab & 5FU/Leucovorin in 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: NCT00252564
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : March 14, 2011
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Memorial Sloan Kettering Cancer Center
Prologue Research International
Information provided by (Responsible Party):
US Oncology Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Fluorouracil
Drug: Cetuximab
Enrollment 247
Recruitment Details A total of 247 patients were recruited from multiple research sites and were randomly assigned to either Arm A or Arm B between December 2005 to June 2007.
Pre-assignment Details The patients were required to be in screening for up to 3 weeks prior to registering the patient for randomization
Arm/Group Title Arm A Arm B
Hide Arm/Group Description

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

Period Title: Overall Study
Started 124 [1] 123 [1]
Completed 85 [2] 79 [2]
Not Completed 39 44
Reason Not Completed
Adverse Event             17             13
Unrelated Complication             2             1
Disease Progression             14             20
Death             0             3
Physician Decision             1             0
Lost to Follow-up             1             0
Patient Request             4             5
Withdrawal by Subject             0             2
[1]
From randomization
[2]
Received 6+ cycles OR had response (RECIST criteria, CR or PR)
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

Total of all reporting groups
Overall Number of Baseline Participants 124 123 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
73
  58.9%
67
  54.5%
140
  56.7%
>=65 years
51
  41.1%
56
  45.5%
107
  43.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 123 participants 247 participants
61  (12) 63  (11) 62  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
Female
54
  43.5%
50
  40.7%
104
  42.1%
Male
70
  56.5%
73
  59.3%
143
  57.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
American Indian or Alaska Native
2
   1.6%
0
   0.0%
2
   0.8%
Asian
3
   2.4%
3
   2.4%
6
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  12.1%
15
  12.2%
30
  12.1%
White
100
  80.6%
99
  80.5%
199
  80.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.2%
6
   4.9%
10
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 124 participants 123 participants 247 participants
124 123 247
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description

From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).

Kaplan-Meier median PFS time and PFS rate (at 12 months)

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

Overall Number of Participants Analyzed 124 123
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(9.2 to 13.6)
8.3
(6.7 to 9.7)
2.Primary Outcome
Title Progression-free Survival (PFS) Rate at 1 Year.
Hide Description From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

Overall Number of Participants Analyzed 124 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants w/ PFS at 1yr
0.45
(0.34 to 0.55)
0.32
(0.23 to 0.42)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description

From randomization to death (event); or last follow-up date if alive (censoring).

Kaplan-Meier OS median time.

Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

Overall Number of Participants Analyzed 124 123
Median (95% Confidence Interval)
Unit of Measure: Months
21.3
(18.2 to 25.2)
19.5
(16.5 to 21.6)
4.Secondary Outcome
Title Objective Response Rate
Hide Description Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all “per-protocol population” patients.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis included all eligible and treated patients, i.e. per-protocol population. A patient will be considered in the arm he/she is actually treated, not randomized.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

Overall Number of Participants Analyzed 117 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.1
(42.7 to 61.5)
41.2
(32.2 to 50.6)
Time Frame during the whole treatment period, up to 30 days following last dose
Adverse Event Reporting Description for treated patients only, assessed at each treatment visit
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description

(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle

(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU

All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/118 (33.90%)      49/121 (40.50%)    
Blood and lymphatic system disorders     
LEUKOPENIA  1  0/118 (0.00%)  0 1/121 (0.83%)  2
NEUTROPENIA  1  1/118 (0.85%)  1 0/121 (0.00%)  0
THROMBOCYTOPENIA  1  1/118 (0.85%)  2 0/121 (0.00%)  0
Cardiac disorders     
BRADYCARDIA  1  1/118 (0.85%)  1 0/121 (0.00%)  0
FIBRILLATION ATRIAL  1  2/118 (1.69%)  2 2/121 (1.65%)  2
CARDIAC ARREST  1  1/118 (0.85%)  1 0/121 (0.00%)  0
FAILURE HEART CONGESTIVE  1  2/118 (1.69%)  2 2/121 (1.65%)  2
HYPERTENSION  1  0/118 (0.00%)  0 1/121 (0.83%)  2
HYPOTENSION  1  0/118 (0.00%)  0 2/121 (1.65%)  3
MYOCARDIAL INFARCT  1  0/118 (0.00%)  0 1/121 (0.83%)  1
Endocrine disorders     
KETOSIS  1  1/118 (0.85%)  1 0/121 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  0/118 (0.00%)  0 1/121 (0.83%)  1
ABDOMINAL PAIN  1  0/118 (0.00%)  0 3/121 (2.48%)  3
BOWEL OBSTRUCTION  1  3/118 (2.54%)  3 1/121 (0.83%)  1
BOWEL PERFORATION  1  0/118 (0.00%)  0 1/121 (0.83%)  1
COLITIS  1  0/118 (0.00%)  0 1/121 (0.83%)  1
COLON OBSTRUCTION  1  0/118 (0.00%)  0 1/121 (0.83%)  1
COLON ULCER  1  1/118 (0.85%)  1 0/121 (0.00%)  0
CONSTIPATION  1  1/118 (0.85%)  1 1/121 (0.83%)  1
DEHYDRATION  1  3/118 (2.54%)  3 7/121 (5.79%)  8
DIARRHEA  1  3/118 (2.54%)  3 3/121 (2.48%)  3
ENTEROCOLITIS  1  0/118 (0.00%)  0 1/121 (0.83%)  1
ESOPHAGITIS  1  0/118 (0.00%)  0 1/121 (0.83%)  1
FECAL IMPACTION  1  0/118 (0.00%)  0 1/121 (0.83%)  1
GASTROENTERITIS  1  1/118 (0.85%)  1 0/121 (0.00%)  0
GASTROINTESTINAL PERFORATION (NOS)  1  0/118 (0.00%)  0 1/121 (0.83%)  1
ILEUS  1  1/118 (0.85%)  3 0/121 (0.00%)  0
INTESTINAL OBSTRUCTION  1  2/118 (1.69%)  2 4/121 (3.31%)  4
NAUSEA  1  0/118 (0.00%)  0 2/121 (1.65%)  2
STOMATITIS  1  1/118 (0.85%)  2 0/121 (0.00%)  0
VOMITING  1  0/118 (0.00%)  0 2/121 (1.65%)  2
GASTROINTESTINAL HEMORRHAGE  1  1/118 (0.85%)  1 2/121 (1.65%)  2
RECTAL HEMORRHAGE  1  0/118 (0.00%)  0 1/121 (0.83%)  1
PERITONITIS  1  0/118 (0.00%)  0 1/121 (0.83%)  1
General disorders     
PAIN  1  1/118 (0.85%)  1 1/121 (0.83%)  2
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/118 (0.85%)  1 0/121 (0.00%)  0
CHOLELITHIASIS  1  1/118 (0.85%)  2 0/121 (0.00%)  0
JAUNDICE  1  0/118 (0.00%)  0 1/121 (0.83%)  1
Immune system disorders     
ALLERGIC REACTION  1  1/118 (0.85%)  2 0/121 (0.00%)  0
ANAPHYLACTIC REACTION  1  0/118 (0.00%)  0 2/121 (1.65%)  2
AUTOIMMUNE DEFICIENCY SYNDROME  1  1/118 (0.85%)  1 0/121 (0.00%)  0
Infections and infestations     
FEBRILE NEUTROPENIA  1  3/118 (2.54%)  3 0/121 (0.00%)  0
INFECTION  1  2/118 (1.69%)  2 0/121 (0.00%)  0
SEPSIS  1  1/118 (0.85%)  1 4/121 (3.31%)  4
Metabolism and nutrition disorders     
HYPERGLYCEMIA  1  1/118 (0.85%)  2 0/121 (0.00%)  0
HYPOMAGNESEMIA  1  0/118 (0.00%)  0 1/121 (0.83%)  2
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  1/118 (0.85%)  2 0/121 (0.00%)  0
FRACTURE BONE  1  1/118 (0.85%)  1 0/121 (0.00%)  0
PATHOLOGICAL FRACTURE  1  1/118 (0.85%)  1 0/121 (0.00%)  0
Nervous system disorders     
DEPRESSION  1  0/118 (0.00%)  0 1/121 (0.83%)  2
HEADACHE  1  1/118 (0.85%)  2 0/121 (0.00%)  0
MENTAL DETERIORATION  1  0/118 (0.00%)  0 1/121 (0.83%)  1
SPINAL CORD COMPRESSION  1  1/118 (0.85%)  1 0/121 (0.00%)  0
SYNCOPE  1  1/118 (0.85%)  2 0/121 (0.00%)  0
Renal and urinary disorders     
ACUTE KIDNEY FAILURE  1  1/118 (0.85%)  1 0/121 (0.00%)  0
ELECTROLYTE ABNORMALITY  1  0/118 (0.00%)  0 1/121 (0.83%)  1
KIDNEY STONE  1  0/118 (0.00%)  0 1/121 (0.83%)  2
URINARY TRACT INFECTION  1  0/118 (0.00%)  0 1/121 (0.83%)  2
Respiratory, thoracic and mediastinal disorders     
CHEST PAIN  1  0/118 (0.00%)  0 3/121 (2.48%)  3
DYSPNEA  1  2/118 (1.69%)  3 1/121 (0.83%)  1
PLEURAL EFFUSION  1  0/118 (0.00%)  0 1/121 (0.83%)  2
PNEUMONIA  1  0/118 (0.00%)  0 3/121 (2.48%)  3
PNEUMONITIS  1  1/118 (0.85%)  1 0/121 (0.00%)  0
PULMONARY EMBOLISM  1  2/118 (1.69%)  2 3/121 (2.48%)  3
PULMONARY EMBOLUS  1  1/118 (0.85%)  1 3/121 (2.48%)  3
RESPIRATORY FAILURE  1  1/118 (0.85%)  1 0/121 (0.00%)  0
HYDRONEPHROSIS  1  0/118 (0.00%)  0 1/121 (0.83%)  2
Skin and subcutaneous tissue disorders     
HEALING ABNORMAL  1  0/118 (0.00%)  0 1/121 (0.83%)  1
HERNIA  1  0/118 (0.00%)  0 1/121 (0.83%)  1
NAIL DISORDER  1  0/118 (0.00%)  0 1/121 (0.83%)  1
PYODERMA (SKIN INFECTION)  1  0/118 (0.00%)  0 1/121 (0.83%)  1
Vascular disorders     
ARTERIOSCLEROSIS  1  0/118 (0.00%)  0 1/121 (0.83%)  1
THROMBOPHLEBITIS  1  1/118 (0.85%)  2 1/121 (0.83%)  1
THROMBOSIS  1  4/118 (3.39%)  4 7/121 (5.79%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, 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%
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   117/118 (99.15%)      120/121 (99.17%)    
Blood and lymphatic system disorders     
ANEMIA  1  45/118 (38.14%)  93 28/121 (23.14%)  57
LEUKOPENIA  1  37/118 (31.36%)  142 26/121 (21.49%)  124
NEUTROPENIA  1  49/118 (41.53%)  178 19/121 (15.70%)  87
THROMBOCYTOPENIA  1  42/118 (35.59%)  160 22/121 (18.18%)  66
EDEMA  1  12/118 (10.17%)  17 9/121 (7.44%)  18
HYPOCALCEMIA  1  6/118 (5.08%)  8 1/121 (0.83%)  3
Cardiac disorders     
HYPERTENSION  1  21/118 (17.80%)  32 15/121 (12.40%)  41
HYPOTENSION  1  1/118 (0.85%)  1 7/121 (5.79%)  8
Gastrointestinal disorders     
ABDOMINAL PAIN  1  26/118 (22.03%)  36 23/121 (19.01%)  25
ANOREXIA  1  31/118 (26.27%)  51 29/121 (23.97%)  33
CONSTIPATION  1  30/118 (25.42%)  42 36/121 (29.75%)  44
DEHYDRATION  1  17/118 (14.41%)  22 8/121 (6.61%)  8
DIARRHEA  1  53/118 (44.92%)  110 50/121 (41.32%)  105
DYSGEUSIA  1  7/118 (5.93%)  10 5/121 (4.13%)  5
DYSPHAGIA  1  7/118 (5.93%)  7 2/121 (1.65%)  2
HEARTBURN  1  8/118 (6.78%)  9 2/121 (1.65%)  2
HEMORRHOIDS  1  3/118 (2.54%)  3 8/121 (6.61%)  10
MUCOSITIS NOS  1  14/118 (11.86%)  22 16/121 (13.22%)  26
NAUSEA  1  59/118 (50.00%)  94 54/121 (44.63%)  103
STOMATITIS  1  6/118 (5.08%)  7 19/121 (15.70%)  23
VOMITING  1  32/118 (27.12%)  44 24/121 (19.83%)  31
HYPOMAGNESEMIA  1  10/118 (8.47%)  16 26/121 (21.49%)  27
General disorders     
ASTHENIA  1  13/118 (11.02%)  19 22/121 (18.18%)  31
CHILLS  1  9/118 (7.63%)  13 5/121 (4.13%)  5
FATIGUE  1  55/118 (46.61%)  115 40/121 (33.06%)  71
FEVER  1  15/118 (12.71%)  18 16/121 (13.22%)  20
INSOMNIA  1  16/118 (13.56%)  19 16/121 (13.22%)  17
WEAKNESS GENERALIZED  1  8/118 (6.78%)  9 9/121 (7.44%)  10
WEIGHT LOSS  1  19/118 (16.10%)  35 17/121 (14.05%)  22
EPISTAXIS  1  27/118 (22.88%)  30 18/121 (14.88%)  22
PAIN  1  20/118 (16.95%)  36 34/121 (28.10%)  51
Immune system disorders     
ALLERGIC REACTION  1  9/118 (7.63%)  13 4/121 (3.31%)  4
HYPERSENSITIVITY  1  20/118 (16.95%)  42 0/121 (0.00%)  0
Infections and infestations     
INFECTION  1  8/118 (6.78%)  13 23/121 (19.01%)  27
Metabolism and nutrition disorders     
HYPERGLYCEMIA  1  11/118 (9.32%)  20 7/121 (5.79%)  11
HYPOKALEMIA  1  8/118 (6.78%)  13 13/121 (10.74%)  20
PROTEINURIA  1  10/118 (8.47%)  19 5/121 (4.13%)  5
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  6/118 (5.08%)  6 2/121 (1.65%)  2
BACK PAIN  1  12/118 (10.17%)  16 12/121 (9.92%)  16
MUSCLE WEAKNESS  1  7/118 (5.93%)  7 6/121 (4.96%)  6
SHOULDER PAIN  1  6/118 (5.08%)  6 6/121 (4.96%)  6
Nervous system disorders     
DIZZINESS  1  14/118 (11.86%)  14 5/121 (4.13%)  7
HEADACHE  1  16/118 (13.56%)  20 16/121 (13.22%)  18
NEUROPATHY  1  68/118 (57.63%)  127 14/121 (11.57%)  25
PARESTHESIA  1  6/118 (5.08%)  13 0/121 (0.00%)  0
TINGLING  1  6/118 (5.08%)  7 1/121 (0.83%)  1
Psychiatric disorders     
ANXIETY  1  9/118 (7.63%)  9 6/121 (4.96%)  6
DEPRESSION  1  7/118 (5.93%)  8 7/121 (5.79%)  7
Respiratory, thoracic and mediastinal disorders     
CHEST PAIN  1  8/118 (6.78%)  8 11/121 (9.09%)  14
COUGHING  1  19/118 (16.10%)  22 15/121 (12.40%)  18
DYSPNEA  1  18/118 (15.25%)  21 18/121 (14.88%)  19
INFECTION RESPIRATORY  1  6/118 (5.08%)  6 6/121 (4.96%)  6
SORE THROAT  1  7/118 (5.93%)  7 5/121 (4.13%)  7
VOICE ALTERATION  1  6/118 (5.08%)  6 3/121 (2.48%)  3
URINARY TRACT INFECTION  1  6/118 (5.08%)  10 10/121 (8.26%)  14
Skin and subcutaneous tissue disorders     
ACNE  1  2/118 (1.69%)  3 34/121 (28.10%)  79
ALOPECIA  1  15/118 (12.71%)  19 15/121 (12.40%)  16
DRY SKIN  1  3/118 (2.54%)  3 21/121 (17.36%)  44
HAND-FOOT SYNDROME  1  5/118 (4.24%)  10 9/121 (7.44%)  21
NAIL DISORDER  1  5/118 (4.24%)  5 11/121 (9.09%)  17
PRURITUS  1  5/118 (4.24%)  6 10/121 (8.26%)  19
RASH  1  17/118 (14.41%)  26 83/121 (68.60%)  168
Vascular disorders     
THROMBOSIS  1  7/118 (5.93%)  8 10/121 (8.26%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART, CTCAE 3.0
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: Allen L. Cohn
Organization: US Oncology
Phone: 303- 388-4876
EMail: Allen.Cohn@USOncology.com
Layout table for additonal information
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00252564     History of Changes
Other Study ID Numbers: 05-041
First Submitted: November 9, 2005
First Posted: November 11, 2005
Results First Submitted: February 15, 2011
Results First Posted: March 14, 2011
Last Update Posted: February 15, 2019