Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT00728000
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
  • Oxaliplatin — DRUG
    100mg/m2 IV on days 1 and 15 given over 120 mins.
  • Erlotinib — DRUG
    100mg/day PO on days 1-14 and 15-28

Study Details

The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.

Key Dates

First listed
Aug 5, 2008
Start date
Aug 31, 2008
Status verified
Nov 2019
Primary completion
Aug 31, 2009
Completion
Aug 31, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: chemotherapy regimen
    Gemcitabine and oxaliplatin are given intravenously (into the vein) every 2 weeks. Erlotinib is a pill that is taken by mouth daily.

Primary Outcome Measure

The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable. [ Time Frame: 9-10 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45267-

Find similar trials in Cincinnati, OH

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Cincinnati· Cincinnati, OH

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