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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201838
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 14, 2015
Last Update Posted : November 30, 2017
Immunex Corporation
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pancreatic Neoplasms
Interventions: Drug: Gemcitabine
Drug: Etanercept

  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
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 

  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
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 
Overall Participants Analyzed 
[Units: Participants]
 30   8   38 
[Units: Years]
Median (Full Range)
 (46 to 81) 
 (46 to 75) 
 (46 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      14  46.7%      5  62.5%      19  50.0% 
Male      16  53.3%      3  37.5%      19  50.0% 
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

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

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

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

Publications of Results:

Responsible Party: Ohio State University Comprehensive Cancer Center Identifier: NCT00201838     History of Changes
Other Study ID Numbers: OSU-0041
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: November 4, 2014
Results First Posted: August 14, 2015
Last Update Posted: November 30, 2017