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

Completed · Phase 1/Phase 2

Conditions studied: Pancreatic Neoplasms, Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00201838

Run by

Ohio State University Comprehensive Cancer Center

People needed

38

Starts

2001-07-01

Expected to finish

2007-05-01

Last updated by the study team

2017-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma
• No prior chemotherapy, immunology treatments or hormonal treatments
• Measurable disease
• Must be >18 years old
• ONLY CONTROL ARM IS OPEN TO ACCRUAL
• 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.

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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