Status:
COMPLETED
Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Immunex Corporation
Conditions:
Pancreatic Neoplasms
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 effe...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00201838
Start Date
July 1 2001
End Date
May 1 2007
Last Update
November 30 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210