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Phase IB Study of FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Phase 1
18 Years
Open (Enrolling)
Pancreatic Neoplasms

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Trial Information

Phase IB Study of FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma


To define the optimal dose and toxicity of PF-04136309 in combination with FOLFIRINOX
(fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin) in patients
with borderline resectable and locally advanced pancreatic cancer.


- To evaluate the safety of PF-04136309 and FOLFIRINOX by grade 3 or 4 toxicity for
clinical use.

- To determine the tumor control rate (TCR) as defined by stable disease (SD), partial
response (PR), and complete response (CR): TCR = SD + PR + CR.


- To determine the prevalence and function of myeloid-derived suppressor cells (MDSC) in
the bone marrow, peripheral circulation, and tumor before and after treatment with
PF-04136309 and FOLFIRINOX.

- To determine the prevalence and function of MDSC in the bone marrow, peripheral
circulation, and tumor before and after treatment with FOLFIRINOX.

Inclusion Criteria:

- Patient must have histologically or cytologically confirmed pancreatic adenocarcinoma
which is borderline resectable or locally advanced; tumors considered borderline
include the following: (a) no distant metastases; (b) venous involvement of the
superior mesenteric vein/portal vein demonstrating tumor abutment with or without
impingement and narrowing of the lumen, encasement of the superior mesenteric
vein/portal vein but without encasement of the nearby arteries, or short segment
venous occlusion resulting from either tumor thrombus or encasement but with suitable
vessel proximal and distal to the area of vessel involvement, allowing for safe
resection and reconstruction; (c) gastroduodenal artery encasement up to the hepatic
artery with either short segment encasement or direct abutment of the hepatic artery,
without extension to the celiac axis; (d) tumor abutment of the superior mesenteric
artery not to exceed 180 degrees of the circumference of the vessel wall

- Patient must have radiographically measurable disease defined as lesions that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
10 mm with computed tomography (CT) scan or magnetic resonance imaging (MRI) or >= 10
mm with calipers by clinical exam

- Patient myst be >= 18 years of age.

- Patient must have life expectancy of > 6 months

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =<

- Patient must have normal bone marrow and organ function as defined below:

- Absolute neutrophil count >= 1,500/mcl

- Platelets >= 100,000/mcl

- Hemoglobin >= 9.0 g/dL

- Creatinine within normal institutional limits OR creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal limits

- Patient not on anticoagulation must have International Normalized Ratio (INR) and
activated partial thromboplastin time (PTT) < 1.5 x ULN

- Patients with biliary obstruction will need to have stent placed

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she must inform her treating
physician immediately

- Patient must be able to understand and willing to sign an institutional review board
(IRB) approved written informed consent document

Exclusion Criteria:

- Patient must not have evidence of neuroendocrine tumor, duodenal adenocarcinoma, or
ampullary adenocarcinoma

- Patient must not have a history of other malignancy =< 3 years previous with the
exception of basal cell or squamous cell carcinoma of the skin which were treated
with local resection only or carcinoma in situ of the cervix

- Patient must not have received any chemotherapy or radiation for pancreatic cancer

- Patient must not be receiving any other investigational agents

- Patient must not have brain metastases; such patients must be excluded from this
clinical trial because of their poor prognosis and because they often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events

- Patient must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to PF-04136309, 5FU (fluorouracil),
oxaliplatin, or irinotecan hydrochloride

- Patient must not be on any cytochrome P450, family 3, subfamily A, polypeptide 4
(CYP3A4) inhibitors as they may have interaction with PF-04136309

- Patient must not have an uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements

- Patient must not be pregnant and/or breastfeeding

- Patient must not be known to be human immunodeficiency virus (HIV)-positive on
combination antiretroviral therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Optimal dose and dose-limiting toxicity of PF-04136309 in combination with FOLFIRINOX

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

David Linehan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

March 2016

Related Keywords:

  • Pancreatic Neoplasms
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Pancreatic Neoplasms



Washington University School of Medicine Saint Louis, Missouri  63110