Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201838
First received: September 12, 2005
Last updated: August 13, 2015
Last verified: August 2015
Results First Received: November 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pancreatic Neoplasms
Adenocarcinoma
Interventions: Drug: Gemcitabine
Drug: Etanercept

  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
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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
Experimental Group

combination of gemcitabine and etanercept

Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.

Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study.

Control Group Patients received gemcitabine alone

Participant Flow:   Overall Study
    Experimental Group     Control Group  
STARTED     30     8  
Treatment Cohort     30     8  
COMPLETED     30     8  
NOT COMPLETED     0     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
Interventional Arm Patients received Etanercept with gemcitabine
Control Arm Patients received Gemcitabine alone
Total Total of all reporting groups

Baseline Measures
    Interventional Arm     Control Arm     Total  
Number of Participants  
[units: participants]
  30     8     38  
Age  
[units: years]
Median (Full Range)
  59  
  (46 to 81)  
  59  
  (46 to 75)  
  59  
  (46 to 81)  
Gender  
[units: patients]
     
Female     14     5     19  
Male     16     3     19  
Region of Enrollment  
[units: participants]
     
United States     30     8     38  
Metastatic Site  
[units: patients]
     
Liver only     16     0     16  
Liver + other     10     6     16  
other site     4     2     6  
ECOG Performance Status (PS) [1]
[units: patients]
     
PS 0 (Fully active)     7     3     10  
PS 1 (Restricted in physical activity)     21     5     26  
PS 2 (Ambulatory and capable of selfcare)     2     0     2  
[1] Eastern Cooperative Oncology Group (ECOG)



  Outcome Measures
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1.  Primary:   Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation   [ Time Frame: up to 6 months ]

2.  Secondary:   Number of Patients With Response   [ Time Frame: up to 12 months ]

3.  Secondary:   Percentage of Patients With Clinical Benefit Response   [ Time Frame: Up to 12 months ]

4.  Secondary:   Median Overall Survival Rates for Patients   [ Time Frame: up to 1 year ]

5.  Secondary:   Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines   [ Time Frame: up to 6 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
The interpretation of the results for this study is limited by the relatively small patient sample and correlative samples.


  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: Miguel Villalona-Calero, MD
Organization: The Ohio State Unversity Comprehensive Cancer Center
phone: 614-293-5484
e-mail: Miguel.Villalona@osumc.edu


Publications of Results:

Responsible Party: Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201838     History of Changes
Other Study ID Numbers: OSU-0041
Study First Received: September 12, 2005
Results First Received: November 4, 2014
Last Updated: August 13, 2015
Health Authority: United States: Institutional Review Board