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A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

This study has been terminated.
(Study published November 2010 and no further work will be done)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Herbert J. Zeh, III MD, FACS, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00336700
First received: June 12, 2006
Last updated: July 27, 2016
Last verified: July 2016
Results First Received: December 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Gemcitabine
Drug: Erlotinib

  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 (900-1500 mg/m2) + Erlotinib (50-150 mg Daily) Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.

Participant Flow:   Overall Study
    Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)
STARTED   25 
COMPLETED   25 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily) Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.

Baseline Measures
   Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily) 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 66 
 (34 to 81) 
Gender 
[Units: Participants]
 
Female   16 
Male   9 


  Outcome Measures
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1.  Primary:   Recurrence Free Survival (RFS)   [ Time Frame: Up to 60 months ]

2.  Primary:   1-year Recurrence Free Survival (RFS)   [ Time Frame: Up to 60 months ]

3.  Primary:   2-year Recurrence Free Survival (RFS)   [ Time Frame: Up to 60 months ]

4.  Secondary:   Estimated 1&2 Year Overall Survival (OS)   [ Time Frame: Up to 60 months ]

5.  Secondary:   Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)   [ Time Frame: Up to 60 months ]

6.  Secondary:   KRAS Mutational Status   [ Time Frame: Up to 60 months ]


  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: Herbert Zeh, MD
Organization: UPMC CancerCenter
phone: 412-692-2852
e-mail: zehxhx@upmc.edu



Responsible Party: Herbert J. Zeh, III MD, FACS, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00336700     History of Changes
Other Study ID Numbers: 06-016
Study First Received: June 12, 2006
Results First Received: December 23, 2015
Last Updated: July 27, 2016
Health Authority: United States: Food and Drug Administration