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Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00305877
First received: March 21, 2006
Last updated: May 6, 2014
Last verified: December 2012
Results First Received: September 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Interventions: Biological: cetuximab
Drug: gemcitabine hydrochloride
Drug: capecitabine
Radiation: radiation therapy
Biological: bevacizumab
Other: laboratory biomarker analysis

  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
This study was activated on February 17, 2006 and terminated on January 9, 2008 with final accrual of 137 patients.

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
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.

Participant Flow:   Overall Study
    Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)     Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)  
STARTED     69     68  
Treated     67     63  
Eligible     66     66  
Included in Efficacy Analysis     65     62  
COMPLETED     45     34  
NOT COMPLETED     24     34  
Lack of Efficacy                 6                 9  
Adverse Event                 9                 14  
Death                 0                 1  
Withdrawal by Subject                 4                 2  
Physician Decision                 1                 1  
Never start treatment                 2                 5  
Ineligible                 2                 1  
Transportation issue with daily RT                 0                 1  



  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.
All treated patients are included in this analysis.

Reporting Groups
  Description
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation) Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation) Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
Total Total of all reporting groups

Baseline Measures
    Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)     Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)     Total  
Number of Participants  
[units: participants]
  67     63     130  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 29.2 to 92.9 )  
  60  
  ( 41.6 to 79.4 )  
  60  
  ( 29.2 to 92.9 )  
Gender  
[units: participants]
     
Female     35     30     65  
Male     32     33     65  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy   [ Time Frame: Every 2 weeks while on treatment and for 30 days after the end of treatment ]

2.  Secondary:   Two-year Overall Survival Rate   [ Time Frame: Assessed every 3 months for 2 years ]

3.  Secondary:   Two-year Disease-free Survival (DFS)   [ Time Frame: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00305877     History of Changes
Other Study ID Numbers: NCI-2012-02969, NCI-2012-02969, CALGB-ECOG-E2204, SWOG-ECOG-E2204, ECOG-E2204, NCCTG-ECOG-E2204, E2204, E2204, U10CA021115
Study First Received: March 21, 2006
Results First Received: September 24, 2013
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration