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Trial record 1 of 1 for:    NCCTG N0949
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Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01279681
Recruitment Status : Terminated (Slow accrual)
First Posted : January 19, 2011
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cognitive/Functional Effects
Colorectal Cancer
Neurotoxicity
Interventions Biological: bevacizumab
Drug: capecitabine
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Enrollment 32
Recruitment Details Thirty-two participants were enrolled between January 2011 and December 2012. The trial was terminated prematurely due to poor accrual and limited cooperative group resources. All follow-up was discontinued November 1, 2014.
Pre-assignment Details Prior to randomization, physician chose fluoropyrimidine type [ie, oral Capecitabine (Xeloda) or infusional 5FU]. Patient was randomly assigned to arm A [fluoropyrimidine + bevacizumab (BEV)] or arm B [fluoropyrimidine/oxaliplatin (OXAL) + BEV] using chosen fluoropyrimidine. LV=Leucovorin, mFOLFOX7=5FU+LV+OXAL.
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Hide Arm/Group Description Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 15 17
Completed 0 0
Not Completed 15 17
Reason Not Completed
Disease Progression             9             6
Withdrawal by Subject             3             4
Adverse Event             2             3
Death             0             1
Withdrawal Prior to Beginning Treatment             0             1
Physician Decision             1             0
Other Reason             0             2
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV] Total
Hide Arm/Group Description Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
75
(71 to 81)
77
(71 to 86)
75.5
(71 to 86)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
70-74 years
7
  46.7%
7
  41.2%
14
  43.8%
75-79 years
7
  46.7%
7
  41.2%
14
  43.8%
80-84 years
1
   6.7%
2
  11.8%
3
   9.4%
85+ years
0
   0.0%
1
   5.9%
1
   3.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
6
  40.0%
6
  35.3%
12
  37.5%
Male
9
  60.0%
11
  64.7%
20
  62.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
White
13
  86.7%
17
 100.0%
30
  93.8%
Black or African American
2
  13.3%
0
   0.0%
2
   6.3%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
0-1
14
  93.3%
15
  88.2%
29
  90.6%
2
1
   6.7%
2
  11.8%
3
   9.4%
[1]
Measure Description: Performance Status was defined as 0=Asymptomatic and fully active, 1=Symptomatic and fully ambulatory, 2=Symptomatic and ambulatory.
Number of Metastatic Sites  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
1
5
  33.3%
5
  29.4%
10
  31.3%
>1
10
  66.7%
12
  70.6%
22
  68.8%
Physician determined 5-FU choice prior to randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Infusional
7
  46.7%
13
  76.5%
20
  62.5%
Capecitabine
8
  53.3%
4
  23.5%
12
  37.5%
1.Primary Outcome
Title Progression-Free Survival
Hide Description Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the time (in months) from the date of randomization to the date of documented disease progression or death, whichever occurs first. Patients were followed until progression (and progression was declared) regardless of whether the patient was on the first line treatment or not. Patients who progress following a missed scan will have their date of progression back-dated to the date of missing scan. Patients without a progression who are still alive at the time of analysis will be censored at the date of last follow-up.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant who refused to initiate study treatment following randomization was excluded from the analysis.
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Hide Arm/Group Description:
Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 16
Median (Full Range)
Unit of Measure: months
6.7
(5.7 to 13.4)
6.7
(6.0 to 10.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A [Fluoropyrimidine + Bevacizumab (BEV)], Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.49 to 2.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time (in months) from randomization to death.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant who refused to initiate study treatment following randomization was excluded from the analysis.
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Hide Arm/Group Description:
Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 16
Median (Full Range)
Unit of Measure: months
18.8
(16.1 to 29.3)
15.4 [1] 
(9.9 to NA)
[1]
Upper limit of 95% CI is not attainable due to insufficient number of participants with events
3.Secondary Outcome
Title Response Rate, Defined as the Percentage of Patients in Each Arm Who Have an Objective Status of Complete Response or Partial Response, Confirmed by a Second Assessment Measured at Least 6 Weeks From the Initial Assessment
Hide Description

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

  • Complete Response (CR): disappearance of all target lesions;
  • Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
  • Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
  • Stable Disease (SD): small changes that do not meet above criteria.

Response rate is reported as the percentage of participants who achieved Complete Response or Partial Response.

Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant who refused to initiate study treatment following randomization was excluded from the analysis.
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Hide Arm/Group Description:
Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47
(21 to 73)
38
(15 to 65)
4.Secondary Outcome
Title Number of Participants With Grade 3 Adverse Events At Least Possibly Related to Treatment
Hide Description Adverse events were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame Up to 42 days after treatment discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant who refused to initiate study treatment following randomization was excluded from the analysis.
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Hide Arm/Group Description:
Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 16
Measure Type: Count of Participants
Unit of Measure: Participants
Palmar-plantar erythrodysesthesia 5 1
Hypertension 2 4
Thromboembolic events 1 1
Anemia 0 1
Neutropenia 0 1
Nausea 1 0
Vomiting 0 1
Mucositis 1 1
Fatigue 2 1
Peripheral sensory neuropathy 0 1
Fall 1 0
Anorexia 2 0
Hyperglycemia 0 1
Hyponatremia 2 1
Dysesthesia 0 1
Ejection fraction descreased 0 1
Chronic kidney disease 0 1
Back pain 0 1
5.Other Pre-specified Outcome
Title Change in Geriatric/Frailty Using the North Central Cancer Treatment Group (NCCTG) Brief Frailty Inventory and the Rockwood Frailty Index Physician and Patient-reported Items
Hide Description The various measures of geriatric/frailty (Canadian Geriatric Society [CGSA], Rockwood, and NCCTG measures) will be compared head to head using Bland-Altman methods to assess the differences between clinician and patient reported frailty and the relative information obtained from the various assessments. This will be the first head to head comparison of its type to assess geriatric/frailty measures.
Time Frame Baseline to 42 days after termination of study treatment
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Change in QOL Using the Fatigue/Uniscale Assessment, Linear Analog Self-Assessment (LASA), and the European Quality of Live Five Dimensions Questionnaire (EQ-5D)
Hide Description A cut-point of 5 or lower on the overall QoL question will be defined to be the primary cut-off for analysis as that has been demonstrated to represent clinically deficient QoL.
Time Frame Baseline to up to 42 days after termination of study treatment
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Proportion of Patients Reporting Satisfaction Using the Was It Worth IT (WIWI) Questionnaire
Hide Description WIWI will be summarized descriptively to identify the number of patients who were satisfied with each treatment and indications for improvements therein. Proportion of patients' satisfaction will be compared between treatments by a Fisher’s exact test. The impact of the clinical trial on patient QOL will be summarized via means and standard deviations and compared between treatment arms via a Wilcoxon rank sum test.
Time Frame Baseline to up to 42 days after termination of study treatment
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Overall Incidence of Grade >= 3 Toxicity in Elderly Patients
Hide Description A logistic regression model will be used to determine the odd ratios for the occurrence of grade 3 + toxicity with a 95% confidence interval, and the overall association will be assessed by a likelihood ratio test with a two-sided alpha level of 0.05. As a secondary analysis, a multivariate logistic model will be applied including covariates for treatment arm and the stratification factors: age, PS and metastatic sites.
Time Frame Up to 42 days after discontinuation of treatment
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Prognostic Single-nucleotide Polymorphisms (SNPs) for Grade 3+ Hypertension
Hide Description Logistic regression models and conditional inference trees (or more generally conditional random forests) will be used to construct multi-variable models based on the SNPs identified as interesting.
Time Frame Up to 42 days after treatment discontinuation
Outcome Measure Data Not Reported
Time Frame Up to 3 years
Adverse Event Reporting Description Excluded one participant who refused to initiate study treatment following randomization.
 
Arm/Group Title Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Hide Arm/Group Description Patients receive either 5FU/LV or Capecitabine, plus BEV. 5FU/LV + BEV is comprised of 5FU IV over 46-48 hours, LV calcium IV over 2 hours, and BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Capecitabine + BEV is comprised of capecitabine PO BID on days 1-14 and BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive either mFOLFOX7 plus BEV, or Capecitabine + OXAL (XELOX) plus BEV. mFOLFOX7 + BEV is comprised of OXAL IV over 2 hours, LV calcium IV over 2 hours, and 5FU IV over 46-48 hours on day 1. Patients also receive BEV IV over 10-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. XELOX + BEV is comprised of OXAL IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Patients also receive BEV IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/15 (33.33%)      3/16 (18.75%)    
Cardiac disorders     
Atrial fibrillation  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Colonic obstruction  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Colonic perforation  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Constipation  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Diarrhea  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Mucositis oral  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Nausea  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Vomiting  1  0/15 (0.00%)  0 1/16 (6.25%)  1
General disorders     
Edema limbs  1  1/15 (6.67%)  2 0/16 (0.00%)  0
Fatigue  1  2/15 (13.33%)  2 0/16 (0.00%)  0
Immune system disorders     
Allergic reaction  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Skin infection  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Hyperglycemia  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Hyponatremia  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorder - Other, specify  1  1/15 (6.67%)  2 0/16 (0.00%)  0
Vascular disorders     
Hypertension  1  2/15 (13.33%)  3 0/16 (0.00%)  0
Hypotension  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      16/16 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  0/15 (0.00%)  0 3/16 (18.75%)  6
Gastrointestinal disorders     
Abdominal pain  1  7/15 (46.67%)  13 2/16 (12.50%)  3
Constipation  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Diarrhea  1  11/15 (73.33%)  73 11/16 (68.75%)  41
Dysphagia  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Enterocolitis  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Esophagitis  1  2/15 (13.33%)  2 2/16 (12.50%)  3
Mucositis oral  1  7/15 (46.67%)  33 6/16 (37.50%)  14
Nausea  1  12/15 (80.00%)  33 8/16 (50.00%)  31
Rectal perforation  1  0/15 (0.00%)  0 1/16 (6.25%)  2
Vomiting  1  7/15 (46.67%)  12 3/16 (18.75%)  3
General disorders     
Edema limbs  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Fatigue  1  14/15 (93.33%)  129 15/16 (93.75%)  106
Fever  1  1/15 (6.67%)  3 1/16 (6.25%)  1
Localized edema  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations     
Bladder infection  1  2/15 (13.33%)  4 0/16 (0.00%)  0
Lung infection  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Pharyngitis  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Upper respiratory infection  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Urinary tract infection  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Injury, poisoning and procedural complications     
Fall  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Injury, poisoning and procedural complications - Other, specify  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Wound dehiscence  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Investigations     
Creatinine increased  1  0/15 (0.00%)  0 2/16 (12.50%)  2
Ejection fraction decreased  1  0/15 (0.00%)  0 1/16 (6.25%)  1
INR increased  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Lymphocyte count decreased  1  2/15 (13.33%)  2 1/16 (6.25%)  1
Neutrophil count decreased  1  0/15 (0.00%)  0 3/16 (18.75%)  3
Weight loss  1  7/15 (46.67%)  24 7/16 (43.75%)  10
White blood cell decreased  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Metabolism and nutrition disorders     
Anorexia  1  9/15 (60.00%)  44 8/16 (50.00%)  33
Dehydration  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Hyperglycemia  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Hypoalbuminemia  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Hypocalcemia  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Hypokalemia  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Hypomagnesemia  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Hyponatremia  1  1/15 (6.67%)  1 2/16 (12.50%)  2
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/15 (6.67%)  3 0/16 (0.00%)  0
Back pain  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Nervous system disorders     
Dysesthesia  1  3/15 (20.00%)  7 5/16 (31.25%)  23
Dysgeusia  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Headache  1  1/15 (6.67%)  2 0/16 (0.00%)  0
Paresthesia  1  5/15 (33.33%)  57 8/16 (50.00%)  32
Peripheral sensory neuropathy  1  7/15 (46.67%)  77 9/16 (56.25%)  65
Stroke  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Syncope  1  0/15 (0.00%)  0 3/16 (18.75%)  3
Psychiatric disorders     
Insomnia  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders     
Chronic kidney disease  1  1/15 (6.67%)  6 1/16 (6.25%)  1
Proteinuria  1  7/15 (46.67%)  22 4/16 (25.00%)  11
Urinary retention  1  0/15 (0.00%)  0 1/16 (6.25%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Pharyngeal mucositis  1  1/15 (6.67%)  2 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders     
Nail loss  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Pain of skin  1  1/15 (6.67%)  1 1/16 (6.25%)  4
Palmar-plantar erythrodysesthesia syndrome  1  6/15 (40.00%)  24 1/16 (6.25%)  6
Skin and subcutaneous tissue disorders - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Vascular disorders     
Hypertension  1  11/15 (73.33%)  79 9/16 (56.25%)  48
Hypotension  1  0/15 (0.00%)  0 2/16 (12.50%)  2
Thromboembolic event  1  3/15 (20.00%)  4 2/16 (12.50%)  2
Vascular disorders - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
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: Joleen M. Hubbard, M.D.
Organization: Mayo Clinic
Phone: 507 284-3121
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01279681     History of Changes
Other Study ID Numbers: N0949
NCCTG-N0949
CDR0000692257 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-02622 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: January 18, 2011
First Posted: January 19, 2011
Results First Submitted: February 23, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017