Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

This study has been terminated.
(The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure).)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00482625
First received: June 4, 2007
Last updated: October 7, 2014
Last verified: March 2014
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Intraductal Papillary Mucinous Neoplasm of the Pancreas
Recurrent Pancreatic Cancer
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Stage III Pancreatic Cancer
Interventions: Drug: erlotinib hydrochloride
Procedure: conventional surgery
Other: immunohistochemistry staining method
Genetic: protein expression analysis
Procedure: biopsy
Other: pharmacological study
Other: laboratory biomarker analysis

  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
Treatment (Enzyme Inhibitor Therapy)

Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.

erlotinib hydrochloride: Given PO

conventional surgery: Undergo pancreatectomy

immunohistochemistry staining method: Correlative studies

protein expression analysis: Correlative studies

biopsy: Correlative studies

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Enzyme Inhibitor Therapy)  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Treatment (Enzyme Inhibitor Therapy)

Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.

erlotinib hydrochloride: Given PO

conventional surgery: Undergo pancreatectomy

immunohistochemistry staining method: Correlative studies

protein expression analysis: Correlative studies

biopsy: Correlative studies

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Enzyme Inhibitor Therapy)  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Mean ± Standard Deviation
  61.17  ± 14.48  
Gender  
[units: participants]
 
Female     3  
Male     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment   [ Time Frame: Pre-treatment and post-treatment ]

2.  Secondary:   Plasma Calculated Concentration - OSI-774 (ng/mL)   [ Time Frame: 20 weeks ]

3.  Secondary:   Pancreas Calculated Concentration - OSI-774 (ng/g)   [ Time Frame: 20 weeks ]

4.  Secondary:   Plasma Calculated Concentration - OSI-420 (ng/mL)   [ Time Frame: 20 weeks ]

5.  Secondary:   Pancreas Calculated Concentration - OSI-420 (ng/g)   [ Time Frame: 20 weeks ]

6.  Secondary:   Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above   [ Time Frame: Up to 20 weeks ]


  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
No text entered.


  More Information
  Hide More Information

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: Dr. Steven Lipkin
Organization: Weill Cornell College of Medicine
phone: 212-774-7160
e-mail: stl2012@med.cornell.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00482625     History of Changes
Other Study ID Numbers: NCI-2009-00898, UCI 06-30, N01CN35160, CDR0000547235
Study First Received: June 4, 2007
Results First Received: April 18, 2014
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration