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

This study has been completed.
Immunex Corporation
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center Identifier:
First received: September 12, 2005
Last updated: October 21, 2016
Last verified: October 2016

The aims of this protocol are:

  1. To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer:
  2. To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation.

Condition Intervention Phase
Pancreatic Neoplasms
Drug: Gemcitabine
Drug: Etanercept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis.

Secondary Outcome Measures:
  • Number of Patients With Response [ Time Frame: up to 12 months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  • Percentage of Patients With Clinical Benefit Response [ Time Frame: Up to 12 months ]
    A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life).

  • Median Overall Survival Rates for Patients [ Time Frame: up to 1 year ]
    Median survival is defined as the time of initiation of the first dose of intervention to the date of death

  • Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines [ Time Frame: up to 6 months ]

Enrollment: 38
Study Start Date: July 2001
Study Completion Date: May 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine.
Drug: 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.
Other Name: Gemzar®
Drug: 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.
Other Name: Enbrel
Active Comparator: Arm II
Patients with pancreatic cancer for which treatment with gemcitabine as a single agent is planned will be asked to participate in this trial as a control group.
Drug: 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.
Other Name: Gemzar®

Detailed Description:

Rationale: The standard treatment for pancreatic cancer is gemcitabine. This study combines gemcitabine with etanercept, a drug that binds with tumor necrosis factor (TNF) molecules and blocks their activity through inhibiting their interaction with cell surface TNF receptors. TNF is the name for a protein in the body that often helps fight foreign substances. However, research suggests that pancreatic tumors develop resistance to TNF and then use it to support cancer growth. Combining etanercept, a TNF inhibitor, with gemcitabine is a novel approach to advanced pancreatic cancer. Because etanercept has not been tested in combination with gemcitabine, a Phase I study will be conducted first to identify the safest dosage of etanercept, and then a Phase II study will evaluate the efficacy of this combination.

Purpose: This study is evaluating the safety of etanercept and gemcitabine for advanced pancreatic cancer in Phase I, and the efficacy of etanercept and gemcitabine for this condition in Phase II. TNF and other inflammatory markers will also be measured in the study.

Treatment: Patients in this study will receive gemcitabine and etanercept. Gemcitabine will be administered through an intravenous infusion weekly for seven weeks followed by one week of rest. Additional treatments with gemcitabine will be given for three weeks followed by one week of rest. Patients will administer etanercept to themselves through a small injection underneath the skin twice each week. Six patients will initially be enrolled in Phase I. If severe side effects appear in at least two patients in Phase I, then additional patients will be enrolled and treated with lower dosages of gemcitabine. When the treatments do not produce unacceptable side effects, the Phase I portion of the study will end and Phase II will begin enrolling patients. Patients in the Phase II portion of the study will also receive gemcitabine and etanercept at the safest dosages identified in Phase I. Several tests and exams will be given throughout both portions of the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma
  • No prior chemotherapy, immunology treatments or hormonal treatments
  • Measurable disease
  • Must be >18 years old

Inclusion Criteria:

  • Pregnant and nursing mothers.
  • Psychiatric disorders that would interfere with consent ability.
  • Patients with known brain or leptomeningeal disease.
  • Patients with history of myocardial infarction with in six previous months.
  • Any concurrent illness that would constitute a hazard to participation in study.
  • Known sensitivity to gemcitabine or etanercept.
  • Prior treatment with etanercept.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00201838

United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Immunex Corporation
Principal Investigator: Miguel Villalona Ohio State University
  More Information

Additional Information:
Responsible Party: Miguel Villalona, Principal Investigator, Ohio State University Comprehensive Cancer Center 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: October 21, 2016

Keywords provided by Ohio State University Comprehensive Cancer Center:
Advanced Stage
Chemotherapy Naive

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents processed this record on May 25, 2017