Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00100815
First received: January 6, 2005
Last updated: November 19, 2015
Last verified: November 2015
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Biological: bevacizumab
Drug: capecitabine
Drug: gemcitabine hydrochloride

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GEMCITABINE, CAPECITABINE and AVASTIN Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.

Participant Flow:   Overall Study
    GEMCITABINE, CAPECITABINE and AVASTIN  
STARTED     50  
COMPLETED     1  
NOT COMPLETED     49  
Progression                 24  
Adverse Event                 18  
Death                 4  
not specified                 3  



  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 and eligible patients

Reporting Groups
  Description
GEMCITABINE, CAPECITABINE and AVASTIN Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.

Baseline Measures
    GEMCITABINE, CAPECITABINE and AVASTIN  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean (Standard Deviation)
  64.18  (11.62)  
Gender  
[units: participants]
 
Female     22  
Male     28  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: every 2-4 months for 1 year and then every 6 months for 5 years ]

2.  Secondary:   Percentage of Participants With Grades 3-5 Treatment Related Toxicities   [ Time Frame: Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years ]

3.  Secondary:   Percentage of Participants With Improved Quality of Life   [ Time Frame: assessed at baseline then weekly for 3 weeks ]

4.  Secondary:   Clinical Response   [ Time Frame: Pre-treatment and every 6 weeks from treatment. ]

5.  Secondary:   Overall Survival   [ Time Frame: every 2-4 months for 1 year and then every 6 months for 5 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
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  More Information
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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


Publications of Results:

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00100815     History of Changes
Other Study ID Numbers: CDR0000409556
RPCI-I-19903
GENENTECH-RPCI-I-19903
Study First Received: January 6, 2005
Results First Received: September 28, 2015
Last Updated: November 19, 2015
Health Authority: United States: Food and Drug Administration