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A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas

Phase 2
18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas

Inclusion Criteria

Enrollment/ eligibility criteria:

- 18 years of age or older

- Able to understand and provide written informed consent

- Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of
the pancreas based on CT and MRI findings as detailed below by "Definition of...."

Treatment Eligibility Criteria:

- Have an ECOG performance status less than or equal to 2

- Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas

- Have adequate organ and bone marrow function as defined by:

- total leukocytes greater than or equal to 3 x1000/μL

- absolute neutrophil count (ANC) > or equal to 1.5x 1000/μL

- hemoglobin > or equal to 9 g/dL

- platelets > or equal to 100 x 1000/μL

- creatinine clearance >60 mL/min or creatinine < or equal to 1.5 mg/dL

- bilirubin < or equal to 2 mg/dL or >2 and declining as described in the

- aspartate transaminases (AST/SGOT) < or equal to3 x ULN

- alanine transaminases (ALT/SGPT) < or equal to 3 x ULN

- Female patients must be post menopausal for > 1 year, surgically sterile, or have a
negative pregnancy test and used at least one form of contraception for 4 weeks prior
to Day 1 of the study, during study treatment and during the first 4 months after
study treatment is discontinued. Male patients must be surgically sterile or use
barrier contraception during the study and for 4 months after the last dose of any
study drug.

Definition of Resectable Pancreatic Cancer includes:

- No evidence of extrapancreatic disease

- No evidence of tumor-arterial abutment (celiac, SMA or HA)

- If tumor induced narrowing of the SMV, PV or SMPV confluence is present it must be
<50% of the diameter of the vessel

- Ca 19-9 <5000, when bilirubin is <2 (or >2 and declining as described in the

Definition of Borderline Resectable Pancreatic Cancer to include at least one of the

- Tumor abutment < or equal to 180 degrees of the SMA or celiac axis

- Tumor abutment or encasement (>180 degrees) of a short segment of the HA

- Tumor induced narrowing of SMV, PV or SMPV of >50% of the diameter of the vessel.

- Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV
below, for reconstruction

- CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based
on multidisciplinary assessment at the MCW weekly pancreatic cancer conference)

- Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or
EUS-guided FNA

- Resectable tumor and CA 19-9 >5000

Exclusion Criteria:

Any patient with one or more of the following will be excluded:

- Have received chemotherapy or chemoradiation within 5 years prior of study enrollment

- Have any previous history of another malignancy (other than cured basal or squamous
cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years
of study enrollment

- Uncontrolled comorbidities including, but not limited to, ongoing or active serious
infection, symptomatic congestive heart failure, unstable angina, unstable cardiac
arrhythmias, psychiatric illness, excessive obesity, or situations that would limit
compliance with the study requirements or the ability to willingly give written
informed consent

- Known HIV, HBV, or HCV infection

- Pregnant or breast-feeding patients or any patient with child-bearing potential not
using contraception 4 weeks prior to, during and 4 months after study treatment is

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Resectability Rate

Outcome Description:

The primary objective is to compare the resectability rate (percent of all patients completing therapy to include surgical resection using a neoadjuvant treatment regimen selected by molecular profiling to historical results with neoadjuvant therapy and surgical resection.

Outcome Time Frame:

At time of surgery

Safety Issue:


Principal Investigator

Douglas B. Evans, M.D., FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Institutional Review Board

Study ID:

MCW 15565



Start Date:

November 2011

Completion Date:

August 2014

Related Keywords:

  • Pancreatic Adenocarcinoma
  • pancreas
  • adenocarcinoma
  • molecular profile
  • molecular profiling
  • pancreatic cancer
  • pancreas cancer
  • cancer
  • molecular target
  • pancreas head
  • pancreas neck
  • pancreas uncinate
  • pancreas body
  • pancreas tail
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226