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Chemotherapy With or Without Bevacizumab in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung 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: NCT00324805
Recruitment Status : Active, not recruiting
First Posted : May 11, 2006
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
Cancer and Leukemia Group B
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology 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 Stage IB Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IIB Non-Small Cell Lung Carcinoma
Stage IIIA Non-small Cell Lung Cancer
Interventions Biological: Bevacizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Drug: Pemetrexed Disodium
Drug: Vinorelbine
Enrollment 1501
Recruitment Details Patients were recruited between June 1, 2007 and September 20, 2013 from ECOG-ACRIN, SWOG, RTOG, CALGB, NCCTG, NCIC-CTG, NSABP, ACOSOG, and CTSU sites.
Pre-assignment Details  
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
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Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 intravenously (IV) on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Period Title: Overall Study
Started 749 752
Started Assigned Therapy 737 735
Completed 599 269
Not Completed 150 483
Reason Not Completed
Adverse Event             62             203
Progression             7             35
Withdrawal by Subject             51             174
Death             6             9
Alternative therapy             4             8
Other complicating disease             1             9
Other reasons             7             26
Other             0             2
Did not start therapy             12             17
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab) Total
Hide Arm/Group Description

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 749 752 1501
Hide Baseline Analysis Population Description
All randomized patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 749 participants 752 participants 1501 participants
60.7  (9.0) 60.8  (8.7) 60.8  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 749 participants 752 participants 1501 participants
Female
374
  49.9%
381
  50.7%
755
  50.3%
Male
375
  50.1%
371
  49.3%
746
  49.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 749 participants 752 participants 1501 participants
Hispanic or Latino
19
   2.5%
29
   3.9%
48
   3.2%
Not Hispanic or Latino
680
  90.8%
688
  91.5%
1368
  91.1%
Unknown or Not Reported
50
   6.7%
35
   4.7%
85
   5.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 749 participants 752 participants 1501 participants
American Indian or Alaska Native
1
   0.1%
5
   0.7%
6
   0.4%
Asian
22
   2.9%
16
   2.1%
38
   2.5%
Native Hawaiian or Other Pacific Islander
3
   0.4%
2
   0.3%
5
   0.3%
Black or African American
74
   9.9%
57
   7.6%
131
   8.7%
White
642
  85.7%
660
  87.8%
1302
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   0.9%
12
   1.6%
19
   1.3%
Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 749 participants 752 participants 1501 participants
Cisplatin/Vinorelbine
187
  25.0%
190
  25.3%
377
  25.1%
Cisplatin/Docetaxel
172
  23.0%
171
  22.7%
343
  22.9%
Cisplatin/Gemcitabine
142
  19.0%
141
  18.8%
283
  18.9%
Cisplatin/Pemetrexed
248
  33.1%
249
  33.1%
497
  33.1%
Unknown/Missing
0
   0.0%
1
   0.1%
1
   0.1%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 749 participants 752 participants 1501 participants
Squamous
216
  28.8%
206
  27.4%
422
  28.1%
Adenocarcinoma
424
  56.6%
450
  59.8%
874
  58.2%
Large cell
22
   2.9%
16
   2.1%
38
   2.5%
Bronchioloalveolar carcinoma (BAC)
8
   1.1%
5
   0.7%
13
   0.9%
Not otherwise specified (NOS)
24
   3.2%
16
   2.1%
40
   2.7%
Combined/mixed
45
   6.0%
48
   6.4%
93
   6.2%
Other
10
   1.3%
10
   1.3%
20
   1.3%
Unknown/missing
0
   0.0%
1
   0.1%
1
   0.1%
Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 749 participants 752 participants 1501 participants
Fully active
439
  58.6%
440
  58.5%
879
  58.6%
Ambulatory
310
  41.4%
310
  41.2%
620
  41.3%
Unknown/missing
0
   0.0%
2
   0.3%
2
   0.1%
Urine protein:creatinine (UPC) ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 749 participants 752 participants 1501 participants
0.31  (3.10) 0.18  (0.92) 0.25  (2.28)
Urine protein  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 749 participants 752 participants 1501 participants
95.26  (32.28) 100.25  (32.28) 97.79  (41.86)
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint.
Time Frame From registration to death, up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
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Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Overall Number of Participants Analyzed 749 752
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
85.8 [2] 
(74.9 to NA)
[1]
The median overall survival and corresponding 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment, i.e. a median has not been reached
[2]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Chemotherapy), Arm II (Chemotherapy, Bevacizumab)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.82 to 1.19
Estimation Comments Arm II versus Arm I
2.Secondary Outcome
Title Disease-free Survival
Hide Description Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment.
Time Frame From registration to death, up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Hide Arm/Group Description:

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Overall Number of Participants Analyzed 749 752
Median (95% Confidence Interval)
Unit of Measure: months
42.9
(36.7 to 57.0)
40.6
(35.5 to 49.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Chemotherapy), Arm II (Chemotherapy, Bevacizumab)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.86 to 1.15
Estimation Comments Arm II vs. Arm I
3.Other Pre-specified Outcome
Title Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description If the difference in the rate of a particular category of toxicities between the 2 arms (N=750 per arm) is at least 5% (4% vs. 9%), 96% power can be attained assuming a significance level of 5% (two-sided Chi Square test) and that the lower toxicity rate for one arm is 4%. A difference in the rates of grade 3-5 arterial thromboembolic events and bleeding events will be monitored and assessed between the treatment arms.
Time Frame Up to 1 year post-treatment
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC.
Hide Description [Not Specified]
Time Frame From registration to death, up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data for these studies were not collected
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Hide Arm/Group Description:

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB – IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting.
Hide Description [Not Specified]
Time Frame From registration to death, up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Hide Arm/Group Description:

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description One patient who did not start treatment submitted an adverse event report
 
Arm/Group Title Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Hide Arm/Group Description

Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Bevacizumab: Given IV

Cisplatin: Given IV

Docetaxel: Given IV

Gemcitabine Hydrochloride: Given IV

Pemetrexed Disodium: Given IV

Vinorelbine: Given IV

All-Cause Mortality
Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   424/738 (57.45%)   563/735 (76.60%) 
Blood and lymphatic system disorders     
Anemia  1  52/738 (7.05%)  40/735 (5.44%) 
Febrile neutropenia  1  31/738 (4.20%)  43/735 (5.85%) 
Cardiac disorders     
Acute coronary syndrome  1  0/738 (0.00%)  1/735 (0.14%) 
Atrial fibrillation  1  2/738 (0.27%)  2/735 (0.27%) 
Atrial flutter  1  0/738 (0.00%)  1/735 (0.14%) 
Cardiac arrest  1  0/738 (0.00%)  1/735 (0.14%) 
Chest pain - cardiac  1  0/738 (0.00%)  1/735 (0.14%) 
Heart failure  1  0/738 (0.00%)  3/735 (0.41%) 
Left ventricular systolic dysfunction  1  1/738 (0.14%)  1/735 (0.14%) 
Myocardial infarction  1  1/738 (0.14%)  7/735 (0.95%) 
Sinus tachycardia  1  0/738 (0.00%)  2/735 (0.27%) 
Cardiac disorders - Other, specify  1  1/738 (0.14%)  0/735 (0.00%) 
Ear and labyrinth disorders     
Hearing impaired  1  6/738 (0.81%)  2/735 (0.27%) 
Tinnitus  1  4/738 (0.54%)  4/735 (0.54%) 
Eye disorders     
Blurred vision  1  1/738 (0.14%)  1/735 (0.14%) 
Photophobia  1  0/738 (0.00%)  1/735 (0.14%) 
Retinal detachment  1  0/738 (0.00%)  1/735 (0.14%) 
Gastrointestinal disorders     
Abdominal distension  1  0/738 (0.00%)  2/735 (0.27%) 
Abdominal pain  1  5/738 (0.68%)  22/735 (2.99%) 
Cheilitis  1  1/738 (0.14%)  0/735 (0.00%) 
Colitis  1  5/738 (0.68%)  2/735 (0.27%) 
Colonic hemorrhage  1  0/738 (0.00%)  2/735 (0.27%) 
Colonic obstruction  1  0/738 (0.00%)  1/735 (0.14%) 
Colonic perforation  1  1/738 (0.14%)  1/735 (0.14%) 
Constipation  1  8/738 (1.08%)  5/735 (0.68%) 
Diarrhea  1  15/738 (2.03%)  31/735 (4.22%) 
Duodenal perforation  1  0/738 (0.00%)  1/735 (0.14%) 
Dyspepsia  1  1/738 (0.14%)  1/735 (0.14%) 
Dysphagia  1  1/738 (0.14%)  2/735 (0.27%) 
Enterocolitis  1  1/738 (0.14%)  1/735 (0.14%) 
Esophageal pain  1  1/738 (0.14%)  0/735 (0.00%) 
Gastric hemorrhage  1  0/738 (0.00%)  1/735 (0.14%) 
Gastritis  1  1/738 (0.14%)  2/735 (0.27%) 
Gastroesophageal reflux disease  1  1/738 (0.14%)  0/735 (0.00%) 
Gastrointestinal pain  1  1/738 (0.14%)  0/735 (0.00%) 
Ileus  1  3/738 (0.41%)  3/735 (0.41%) 
Mucositis oral  1  4/738 (0.54%)  12/735 (1.63%) 
Nausea  1  63/738 (8.54%)  74/735 (10.07%) 
Pancreatitis  1  1/738 (0.14%)  0/735 (0.00%) 
Rectal hemorrhage  1  0/738 (0.00%)  2/735 (0.27%) 
Small intestinal obstruction  1  1/738 (0.14%)  1/735 (0.14%) 
Stomach pain  1  1/738 (0.14%)  1/735 (0.14%) 
Toothache  1  0/738 (0.00%)  1/735 (0.14%) 
Vomiting  1  38/738 (5.15%)  47/735 (6.39%) 
Gastrointestinal disorders - Other  1  1/738 (0.14%)  2/735 (0.27%) 
General disorders     
Fatigue  1  66/738 (8.94%)  92/735 (12.52%) 
Fever  1  0/738 (0.00%)  2/735 (0.27%) 
Infusion site extravasation  1  0/738 (0.00%)  1/735 (0.14%) 
Multi-organ failure  1  0/738 (0.00%)  1/735 (0.14%) 
Non-cardiac chest pain  1  3/738 (0.41%)  6/735 (0.82%) 
Pain  1  2/738 (0.27%)  1/735 (0.14%) 
Sudden death NOS  1  0/738 (0.00%)  1/735 (0.14%) 
Hepatobiliary disorders     
Cholecystitis  1  0/738 (0.00%)  1/735 (0.14%) 
Immune system disorders     
Allergic reaction  1  0/738 (0.00%)  1/735 (0.14%) 
Anaphylaxis  1  7/738 (0.95%)  6/735 (0.82%) 
Autoimmune disorder  1  1/738 (0.14%)  0/735 (0.00%) 
Cytokine release syndrome  1  0/738 (0.00%)  1/735 (0.14%) 
Serum sickness  1  0/738 (0.00%)  1/735 (0.14%) 
Infections and infestations     
Anorectal infection  1  1/738 (0.14%)  0/735 (0.00%) 
Bladder infection  1  0/738 (0.00%)  1/735 (0.14%) 
Bronchial infection  1  3/738 (0.41%)  1/735 (0.14%) 
Catheter related infection  1  0/738 (0.00%)  3/735 (0.41%) 
Device related infection  1  1/738 (0.14%)  0/735 (0.00%) 
Enterocolitis infectious  1  2/738 (0.27%)  2/735 (0.27%) 
Esophageal infection  1  0/738 (0.00%)  1/735 (0.14%) 
Gum infection  1  2/738 (0.27%)  0/735 (0.00%) 
Lung infection  1  8/738 (1.08%)  11/735 (1.50%) 
Pleural infection  1  0/738 (0.00%)  2/735 (0.27%) 
Sepsis  1  4/738 (0.54%)  5/735 (0.68%) 
Skin infection  1  2/738 (0.27%)  1/735 (0.14%) 
Tooth infection  1  0/738 (0.00%)  1/735 (0.14%) 
Upper respiratory infection  1  1/738 (0.14%)  4/735 (0.54%) 
Urinary tract infection  1  4/738 (0.54%)  5/735 (0.68%) 
Infections and infestations - Other  1  10/738 (1.36%)  18/735 (2.45%) 
Injury, poisoning and procedural complications     
Vascular access complication  1  2/738 (0.27%)  3/735 (0.41%) 
Wound dehiscence  1  0/738 (0.00%)  4/735 (0.54%) 
Investigations     
Alanine aminotransferase increased  1  2/738 (0.27%)  0/735 (0.00%) 
Alkaline phosphatase increased  1  1/738 (0.14%)  0/735 (0.00%) 
Aspartate aminotransferase increased  1  2/738 (0.27%)  0/735 (0.00%) 
Cardiac troponin I increased  1  1/738 (0.14%)  0/735 (0.00%) 
Creatinine increased  1  6/738 (0.81%)  9/735 (1.22%) 
INR increased  1  0/738 (0.00%)  1/735 (0.14%) 
Lipase increased  1  1/738 (0.14%)  1/735 (0.14%) 
Lymphocyte count decreased  1  7/738 (0.95%)  11/735 (1.50%) 
Neutrophil count decreased  1  237/738 (32.11%)  273/735 (37.14%) 
Platelet count decreased  1  30/738 (4.07%)  44/735 (5.99%) 
Weight loss  1  1/738 (0.14%)  1/735 (0.14%) 
White blood cell decreased  1  41/738 (5.56%)  42/735 (5.71%) 
Investigations - Other, specify  1  1/738 (0.14%)  1/735 (0.14%) 
Metabolism and nutrition disorders     
Acidosis  1  0/738 (0.00%)  2/735 (0.27%) 
Anorexia  1  9/738 (1.22%)  19/735 (2.59%) 
Dehydration  1  40/738 (5.42%)  45/735 (6.12%) 
Hypercalcemia  1  1/738 (0.14%)  0/735 (0.00%) 
Hyperglycemia  1  11/738 (1.49%)  9/735 (1.22%) 
Hyperkalemia  1  4/738 (0.54%)  1/735 (0.14%) 
Hypoalbuminemia  1  1/738 (0.14%)  3/735 (0.41%) 
Hypocalcemia  1  3/738 (0.41%)  6/735 (0.82%) 
Hypoglycemia  1  0/738 (0.00%)  1/735 (0.14%) 
Hypokalemia  1  20/738 (2.71%)  13/735 (1.77%) 
Hypomagnesemia  1  5/738 (0.68%)  4/735 (0.54%) 
Hyponatremia  1  44/738 (5.96%)  66/735 (8.98%) 
Hypophosphatemia  1  0/738 (0.00%)  4/735 (0.54%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/738 (0.41%)  5/735 (0.68%) 
Back pain  1  0/738 (0.00%)  1/735 (0.14%) 
Bone pain  1  0/738 (0.00%)  1/735 (0.14%) 
Chest wall pain  1  0/738 (0.00%)  1/735 (0.14%) 
Generalized muscle weakness  1  6/738 (0.81%)  7/735 (0.95%) 
Muscle weakness lower limb  1  0/738 (0.00%)  1/735 (0.14%) 
Myalgia  1  4/738 (0.54%)  2/735 (0.27%) 
Neck pain  1  0/738 (0.00%)  1/735 (0.14%) 
Pain in extremity  1  1/738 (0.14%)  1/735 (0.14%) 
Nervous system disorders     
Ataxia  1  1/738 (0.14%)  3/735 (0.41%) 
Cognitive disturbance  1  1/738 (0.14%)  1/735 (0.14%) 
Dizziness  1  4/738 (0.54%)  12/735 (1.63%) 
Dysphasia  1  1/738 (0.14%)  1/735 (0.14%) 
Headache  1  5/738 (0.68%)  18/735 (2.45%) 
Intracranial hemorrhage  1  1/738 (0.14%)  1/735 (0.14%) 
Ischemia cerebrovascular  1  0/738 (0.00%)  1/735 (0.14%) 
Memory impairment  1  0/738 (0.00%)  1/735 (0.14%) 
Neuralgia  1  0/738 (0.00%)  1/735 (0.14%) 
Peripheral motor neuropathy  1  2/738 (0.27%)  1/735 (0.14%) 
Peripheral sensory neuropathy  1  5/738 (0.68%)  5/735 (0.68%) 
Reversible posterior leukoencephalopathy  1  0/738 (0.00%)  3/735 (0.41%) 
Seizure  1  1/738 (0.14%)  3/735 (0.41%) 
Stroke  1  1/738 (0.14%)  0/735 (0.00%) 
Syncope  1  8/738 (1.08%)  10/735 (1.36%) 
Nervous system disorders - Other  1  0/738 (0.00%)  5/735 (0.68%) 
Psychiatric disorders     
Anxiety  1  1/738 (0.14%)  0/735 (0.00%) 
Confusion  1  1/738 (0.14%)  4/735 (0.54%) 
Depression  1  3/738 (0.41%)  0/735 (0.00%) 
Insomnia  1  0/738 (0.00%)  2/735 (0.27%) 
Renal and urinary disorders     
Acute kidney injury  1  6/738 (0.81%)  6/735 (0.82%) 
Chronic kidney disease  1  1/738 (0.14%)  3/735 (0.41%) 
Hematuria  1  0/738 (0.00%)  1/735 (0.14%) 
Proteinuria  1  2/738 (0.27%)  17/735 (2.31%) 
Urinary retention  1  1/738 (0.14%)  0/735 (0.00%) 
Reproductive system and breast disorders     
Testicular pain  1  1/738 (0.14%)  0/735 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  2/738 (0.27%)  1/735 (0.14%) 
Bronchopleural fistula  1  0/738 (0.00%)  2/735 (0.27%) 
Bronchopulmonary hemorrhage  1  0/738 (0.00%)  3/735 (0.41%) 
Cough  1  2/738 (0.27%)  6/735 (0.82%) 
Dyspnea  1  8/738 (1.08%)  17/735 (2.31%) 
Epistaxis  1  2/738 (0.27%)  4/735 (0.54%) 
Hoarseness  1  0/738 (0.00%)  1/735 (0.14%) 
Hypoxia  1  0/738 (0.00%)  5/735 (0.68%) 
Laryngeal edema  1  0/738 (0.00%)  1/735 (0.14%) 
Pleural effusion  1  1/738 (0.14%)  2/735 (0.27%) 
Pneumonitis  1  3/738 (0.41%)  1/735 (0.14%) 
Pulmonary hypertension  1  1/738 (0.14%)  1/735 (0.14%) 
Respiratory failure  1  0/738 (0.00%)  1/735 (0.14%) 
Respiratory thoracic mediastinal - Other  1  1/738 (0.14%)  1/735 (0.14%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  1/738 (0.14%)  3/735 (0.41%) 
Stevens-Johnson syndrome  1  0/738 (0.00%)  1/735 (0.14%) 
Vascular disorders     
Hematoma  1  0/738 (0.00%)  1/735 (0.14%) 
Hypertension  1  19/738 (2.57%)  200/735 (27.21%) 
Hypotension  1  7/738 (0.95%)  11/735 (1.50%) 
Peripheral ischemia  1  0/738 (0.00%)  1/735 (0.14%) 
Thromboembolic event  1  12/738 (1.63%)  33/735 (4.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Chemotherapy) Arm II (Chemotherapy, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   474/738 (64.23%)   509/735 (69.25%) 
Blood and lymphatic system disorders     
Anemia  1  256/738 (34.69%)  183/735 (24.90%) 
General disorders     
Fatigue  1  62/738 (8.40%)  68/735 (9.25%) 
Investigations     
Creatinine increased  1  169/738 (22.90%)  247/735 (33.61%) 
Neutrophil count decreased  1  220/738 (29.81%)  236/735 (32.11%) 
Platelet count decreased  1  48/738 (6.50%)  49/735 (6.67%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  53/738 (7.18%)  58/735 (7.89%) 
Renal and urinary disorders     
Proteinuria  1  3/738 (0.41%)  48/735 (6.53%) 
Vascular disorders     
Hypertension  1  2/738 (0.27%)  50/735 (6.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Center
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00324805     History of Changes
Other Study ID Numbers: NCI-2009-00509
NCI-2009-00509 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000475774 ( Registry Identifier: Clinical Data Repository )
E1505 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1505 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: January 12, 2018
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018