Neoadjuvant GMCI Plus mFOLFIRINOX and Chemoradiation for Non-Metastatic Pancreatic Adenocarcinoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 76
Updated:5/11/2018
Start Date:October 2015
End Date:December 2020

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Neoadjuvant GMCI Plus Modified FOLFIRINOX and Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma

The study will investigate if the addition of GMCI to neoadjuvant mFOLFIRINOX +
chemoradiation is safe and improves the clinical outcome of borderline resectable and
unresectable locally advanced pancreatic adenocarcinoma, as measured by resection rate,
progression-free survival and overall survival.

The current protocol is designed to delivery multiple courses of GMCI timed with a series of
neoadjuvant debulking therapies- modified FOLFIRINOX (mFX) chemotherapy followed by
gemcitabine-radiation (GR) followed by surgery- to capitalize on the synergies with the
different treatment modalities.

This protocol includes two phases: Phase 1b followed by Phase 2. The Phase 1b evaluates the
safety and feasibility of mFX+GR+surgery in combination with GMCI. Patients will be enrolled
on the Phase 1b based on the definition of dose limiting toxicity (DLT), waiting periods and
stopping rules described in the protocol. The Phase 2 is a randomized study comparing a test
group receiving GMCI added to mFX+GR+surgery to a control arm receiving mFX+GR followed by
surgery.

Inclusion Criteria:

- Pathological diagnosis of pancreatic adenocarcinoma before first treatment but may be
enrolled with presumed diagnosis based on clinical and radiologic evaluation with
confirmation made by biopsy at time of EUS prior to AdV-tk injection

- Patients must be deemed to be in adequate health to undergo major surgery
(pancreaticoduodenectomy)

- Tumor accessible for injection that is classified as borderline-resectable or locally
advanced but considered potentially resectable after central review by surgical
investigators. Resection may include major vascular resection with reconstruction as
needed.

- Age 18-76 years

- Performance status ECOG 0-1

- SGOT (AST)<3x upper limit of normal

- Total bilirubin ≤2mg/dl

- Creatinine<2mg/dl

- Calculated creatinine clearance >30ml/m

- WBC>3000/mm3

- Absolute neutrophil count (ANC)>1500/mm3

- Platelets>100,000/mm3

- Hemoglobin > 9 g/dL.

- Patients must give study specific informed consent prior to enrollment

Exclusion Criteria:

- Baseline peripheral sensory neuropathy ≥ grade 2

- Primary hepatic dysfunction including known cirrhosis or active hepatitis. Patients
with biliary obstruction must be stented prior to initiating treatment.

- Evidence of clinically significant pancreatitis as determined by the investigator

- Evidence of significant ascites as determined by the investigator

- Patients on systemic corticosteroids (>10 mg prednisone per day or equivalent) or
other systemic immunosuppressive drugs

- Known to be HIV+

- Pregnant or breast-feeding. Female patients of childbearing age must have negative
serum or urine pregnancy test within 1 week of beginning therapy.

- Other current malignancy (except squamous or basal cell skin cancers)

- Prior abdominal radiation therapy or prior chemotherapy for pancreatic cancer

- Other serious co-morbid illness or compromised organ function

- Known sensitivity or allergic reactions to acyclovir or valacyclovir
We found this trial at
5
sites
Fort Myers, Florida 33907
Principal Investigator: Mark Bloomston, M.D
Phone: 239-430-3263
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Cape Coral, Florida 33990
Phone: 239-430-3263
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Mary Dilhoff, MD
Phone: 614-685-6406
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Fort Myers, Florida 33901
Principal Investigator: Mark Bloomston, MD
Phone: 239-430-3263
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Fort Myers, FL
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15 Vasco de Quiroga
Mexico City, 14080
Phone: +52 (55)54870900
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Mexico City,
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