Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

This study has been terminated.
(Terminated due to low accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00107315
First received: April 5, 2005
Last updated: June 3, 2014
Last verified: June 2014
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: bevacizumab
Drug: capecitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Combination of Capecitabine and Bevacizumab Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.

Participant Flow:   Overall Study
    Combination of Capecitabine and Bevacizumab  
STARTED     16  
COMPLETED     1  
NOT COMPLETED     15  
Disease Progression                 9  
Adverse Event                 4  
Withdrawal by Subject                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
All treated and eligible patients

Reporting Groups
  Description
Combination of Capecitabine and Bevacizumab Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.

Baseline Measures
    Combination of Capecitabine and Bevacizumab  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  78  ± 4.9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     16  
Gender  
[units: participants]
 
Female     11  
Male     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: 1 year ]

2.  Secondary:   Response Rate   [ Time Frame: 1 year ]

3.  Secondary:   Median Survival   [ Time Frame: 1 year ]

4.  Secondary:   Toxicity   [ Time Frame: 1 year ]


  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
Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300


No publications provided


Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00107315     History of Changes
Other Study ID Numbers: I 22204, RPCI-I-22204, GENENTECH-RPCI-I-22204
Study First Received: April 5, 2005
Results First Received: January 8, 2014
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration