CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 1000 mg/m² IV weekly × 7 with 1-week rest, then weekly × 3 with 1-week rest; etanercept self-administered subcutaneously twice weeklyAI-extracted
Key inclusion· 4
  • ✓Pathologically confirmed metastatic or recurrent pancreatic adenocarcinoma
  • ✓No prior chemotherapy, immunologic, or hormonal therapy
  • ✓Measurable disease by imaging
  • ✓Age >18 years
Key exclusion· 7
  • ✕Pregnant or nursing women
  • ✕Psychiatric disorders interfering with informed consent
  • ✕Known brain or leptomeningeal metastases
  • ✕Myocardial infarction within the previous 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00201838
NCT00201838Phase 2Completed
CompareCT.gov

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

Ohio State University Comprehensive Cancer Center·interventional·Posted Sep 20, 2005·Updated Nov 30, 2017

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Etanercept for Pancreatic Neoplasms and Adenocarcinoma. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Neoplasms, Adenocarcinoma
CountriesUnited States
CollaboratorsImmunex Corporation

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJul 1, 2001
Primary CompletionOct 1, 2006
Study CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

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.

Etanerceptdrug

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.