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Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00810719
First received: December 17, 2008
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: January 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Erlotinib
Drug: gemcitabine

  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
Patients were enrolled at University of California Davis and the University of Southern California.

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
Gemcitabine and Erlotinib

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.


Participant Flow:   Overall Study
    Gemcitabine and Erlotinib
STARTED   30 
COMPLETED   30 
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.
No text entered.

Reporting Groups
  Description
Gemcitabine and Erlotinib

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.


Baseline Measures
   Gemcitabine and Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 67 
 (46 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  50.0% 
Male      15  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: Up to 36 months ]

2.  Secondary:   Response Rate   [ Time Frame: Up to 36 months ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 36 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
Due to funding considerations, the study was closed after thirty participants were enrolled.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Analyst
Organization: University of California Davis
phone: 916 734 0294
e-mail: pkaujla@ucdavis.edu


Publications of Results:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00810719     History of Changes
Other Study ID Numbers: UCDCC#211
P30CA093373 ( US NIH Grant/Contract Award Number )
OSI 4132s ( Other Identifier: Genentech )
Study First Received: December 17, 2008
Results First Received: January 13, 2017
Last Updated: March 20, 2017