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Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279681
First Posted: January 19, 2011
Last Update Posted: December 8, 2017
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.
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: February 23, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] 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.
Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV] 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.

Participant Flow:   Overall Study
    Arm A [Fluoropyrimidine + Bevacizumab (BEV)]   Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]
STARTED   15   17 
COMPLETED   0   0 
NOT COMPLETED   15   17 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A [Fluoropyrimidine + Bevacizumab (BEV)] 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.
Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV] 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 Total of all reporting groups

Baseline Measures
   Arm A [Fluoropyrimidine + Bevacizumab (BEV)]   Arm B [Fluoropyrimidine/Oxaliplatin (OXAL) + BEV]   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   17   32 
Age 
[Units: Years]
Median (Full Range)
 75 
 (71 to 81) 
 77 
 (71 to 86) 
 75.5 
 (71 to 86) 
Age, Customized 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      6  40.0%      6  35.3%      12  37.5% 
Male      9  60.0%      11  64.7%      20  62.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of Participants
     
0-1      14  93.3%      15  88.2%      29  90.6% 
    1   6.7%      2  11.8%      3   9.4% 
[1] Performance Status was defined as 0=Asymptomatic and fully active, 1=Symptomatic and fully ambulatory, 2=Symptomatic and ambulatory.
Number of Metastatic Sites 
[Units: Participants]
Count of Participants
     
 5   5   10 
>1   10   12   22 
Physician determined 5-FU choice prior to randomization 
[Units: Participants]
Count of Participants
     
Infusional      7  46.7%      13  76.5%      20  62.5% 
Capecitabine      8  53.3%      4  23.5%      12  37.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival   [ Time Frame: Up to 5 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   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   [ Time Frame: Up to 5 years ]

4.  Secondary:   Number of Participants With Grade 3 Adverse Events At Least Possibly Related to Treatment   [ Time Frame: Up to 42 days after treatment discontinuation ]

5.  Other Pre-specified:   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   [ Time Frame: Baseline to 42 days after termination of study treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Change in QOL Using the Fatigue/Uniscale Assessment, Linear Analog Self-Assessment (LASA), and the European Quality of Live Five Dimensions Questionnaire (EQ-5D)   [ Time Frame: Baseline to up to 42 days after termination of study treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Proportion of Patients Reporting Satisfaction Using the Was It Worth IT (WIWI) Questionnaire   [ Time Frame: Baseline to up to 42 days after termination of study treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Overall Incidence of Grade >= 3 Toxicity in Elderly Patients   [ Time Frame: Up to 42 days after discontinuation of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Prognostic Single-nucleotide Polymorphisms (SNPs) for Grade 3+ Hypertension   [ Time Frame: Up to 42 days after treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: hubbard.joleen@mayo.edu



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