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

NCT00201838 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-11-30

Study results available
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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.

Conditions

  • Pancreatic Neoplasms
  • Adenocarcinoma

Interventions

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.

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.

Sponsors & Collaborators

  • Immunex Corporation

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Miguel Villalona · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2006-10-31
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201838 on ClinicalTrials.gov