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A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Neoplasms, Adenocarcinoma

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Trial Information

A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation

Outcome Time Frame:


Safety Issue:


Principal Investigator

Miguel Villalona

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

July 2001

Completion Date:

May 2007

Related Keywords:

  • Pancreatic Neoplasms
  • Adenocarcinoma
  • Advanced Stage
  • Chemotherapy Naive
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Pancreatic Neoplasms



Ohio State University Medical CenterColumbus, Ohio  43210