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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: Immunex Corporation
• Treatments: Etanercept; Gemcitabine

Criteria

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

• 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.