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7 Day's of Erlotinib Neo-adjuvant, Followed by Adjuvant Erlotinib-gemcitabine in Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT00841035
Recruitment Status : Terminated (Sponsor stopped due to slow enrollment)
First Posted : February 11, 2009
Results First Posted : October 6, 2014
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Marty Heslin, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Drug: erlotinib
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eroltinib Added to Standard of Care
Hide Arm/Group Description

150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles

erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.

Period Title: Phase 1 Overall Study
Started 19 [1]
Completed 6
Not Completed 13
Reason Not Completed
Physician Decision             13
[1]
2 phase enrollment,1st phase enrolled with cancer by fine needle aspiration in endoscopic ultrasound
Period Title: Phase 2 of Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Eroltinib Added to Standard of Care
Hide Arm/Group Description

150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles

erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  94.7%
>=65 years
1
   5.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Epidermal Growth Factor Receptor Signaling(EGFR) in the Presence of Pancreatic Tumor Related to the Mechanism to Erlotinib.
Hide Description It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.
Time Frame During the trial only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eroltinib Added to Standard of Care
Hide Arm/Group Description:
150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Secondary Objectives Include Analysis of Recurrence-free and Overall Survival and the Development of a Predictive Assay for Response to Erlotinib Based on Selected Bio-markers in Endoscopic Ultrasound-Fine-needle Aspiration Specimens.
Hide Description The measurement was to be the average length of time before recurrence of disease and the overall survival time. As well as time from recurrence to death in subjects.This time will be measure in months till recurrence and them months to death.
Time Frame End of the study
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the closure of the study before this endpoint could be met, there are no subjects analyzed.
Arm/Group Title Eroltinib Added to Standard of Care
Hide Arm/Group Description:

150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles

erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline to 36 month or subject death.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eroltinib Added to Standard of Care
Hide Arm/Group Description

150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles

erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.

All-Cause Mortality
Eroltinib Added to Standard of Care
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Eroltinib Added to Standard of Care
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Eroltinib Added to Standard of Care
Affected / at Risk (%) # Events
Total   1/19 (5.26%)    
Cardiac disorders   
Chest Pain  1 [1]  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3
[1]
Subject had long standing history of cardiac disease and developed some chest pain after starting 7 days of erlotinib
Early termination by sponsor and No good clinical data was analyzed to the early termination of the study.
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
Layout table for Results Point of Contact information
Name/Title: Research Nurse Supervisor of Clinical trials
Organization: University of Alabama at Birmingham
Phone: (205)975-0450
EMail: jhrichardson@uabmc.edu
Layout table for additonal information
Responsible Party: Marty Heslin, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00841035     History of Changes
Other Study ID Numbers: F080718006
First Submitted: February 9, 2009
First Posted: February 11, 2009
Results First Submitted: July 3, 2013
Results First Posted: October 6, 2014
Last Update Posted: May 19, 2017