Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

Conditions:Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Age Range:18 - 101
Start Date:December 30, 2016
End Date:May 2020
Contact:Chalaunda Scott

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Perioperative Therapy for Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma With Molecular Correlates

The objective of this study is to estimate the R0 resection rate in patients with Resectable
Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal
Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of
combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).

Patients in both cohorts will receive a total of 3 cycles of neoadjuvant combination
chemotherapy of nab-paclitaxel and gemcitabine, followed by re-staging CT scan, if re-staging
CT does not show evidence of metastatic disease. Patients will receive SBRT and definitive
surgical resection. Subsequently, patients will receive 3 cycles of adjuvant combination
chemotherapy of nab-paclitaxel and gemcitabine. Each cycle of combination chemotherapy will
be a total of 4 weeks. Patients will be evaluated for response at completion of the 3 cycles
of neoadjuvant combination chemotherapy with CT scans of chest, abdomen and pelvis. Patients
will undergo surveillance CT scan at 3-month intervals until evidence of disease progression.

Inclusion Criteria:

1. Histologically confirmed resectable or borderline resectable pancreatic

2. No evidence of distant metastasis representing stage IV metastatic disease.

3. R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to
superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined
fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal
vein (PV) with no distortion of venous architecture.

4. BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an
interface between the primary tumor and superior mesenteric vein (SMV)-portal vein
(PV) measuring 180o or greater of the circumference of the vein wall, and/or b)
short-segment occlusion of the SMV-PV with normal vein above and below the level of
obstruction that is amenable to resection and venous reconstruction and/or c)
short-segment interface of any degree between tumor and hepatic artery with normal
artery proximal and distal to the interface that is amenable to resection and arterial
reconstruction and/or d) an interface between the tumor and SMA or celiac trunk
measuring less than 180o of the circumference of the artery wall.

5. Age > 18 years old

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

7. Patients must have adequate bone marrow function:

- Platelets >100,000 cells/mm3

- Hemoglobin > 9.0 g/dL

- Absolute Neutrophil Count > 1,500 cells/mm3

8. Patients must have adequate liver function:

- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 X upper
limit of normal

- Alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is
present in the absence of liver metastasis

- Total bilirubin < 1.5 mg/dL

9. Patients must have adequate renal function: creatinine <1.5 mg/dL is recommended;
however, institutional norms are acceptable. Creatinine within institutional limits of
normal or creatinine clearance (CrCl) > 50 mL/min calculated using the Cockcroft-Gault

10. Women of childbearing potential and sexually active males must use an effective
contraception method during treatment and for three months after completing treatment.

11. Negative serum or urine β-human chorionic gonadotropin (hCG) pregnancy test at
screening for patients of childbearing potential.

12. Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE 4.03).

13. Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

1. Patients with locally advanced surgically unresectable PDAC.

2. Patients with evidence of distant metastatic PDAC.

3. Prior chemotherapy or radiation therapy of any kind for treatment of pancreas

4. Prior major surgery within 4 weeks of starting study drug administration.

5. Patient unable or not willing to perform all study related biopsies and blood draws
for exploratory endpoints will not be enrolled on study as all study related
procedures are mandatory.

6. Concomitant treatment with full dose warfarin (coumadin) is NOT allowed. However,
treatment with low molecular weight heparin (LMWH) (such as enoxaparin or dalteparin)
or rivaroxaban is allowed. Patients on full dose warfarin (coumadin) must be
transitioned to either LMWH or rivaroxaban prior to administration of any study
related drugs.

7. Recent or ongoing clinically significant gastrointestinal disorder (e.g.,
malabsorption, bleeding, inflammation, emesis, diarrhea >grade 1).

8. Patients with clinically significant cardiac disease (New York Heart Association
Classification III or IV and cardiac arrhythmias not well controlled with medication),
or myocardial infarction within the previous six months.

9. Serious, uncontrolled, concurrent infection(s) requiring antibiotics.

10. Pregnant or breastfeeding women: positive pregnancy test within 7 days of starting

11. Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer.

12. Participation in any investigational drug study within 4 weeks preceding the start of
study treatment.

13. Patients with external biliary drains.
We found this trial at
Aurora, Colorado 80045
Principal Investigator: Wells Messersmith, MD
Phone: 720-848-2538
Aurora, CO
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