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Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer

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Trial Information

Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients With Borderline Resectable Pancreatic Adenocarcinoma: An Intergroup Single-Arm Pilot Study


Patients receive mFOLFIRINOX chemotherapy comprising oxaliplatin intravenously 85 mg/m2 (IV)
over 2 hours on day 1, irinotecan 180 mg/m2 IV over 90 minutes on day 1, leucovorin calcium
400 mg/m2 IV over 2 hours on day 1, and 5-fluorouracil 2,400 mg/m2 IV over 46-48 hours on
days 1-2. Treatment repeats every 14 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

Beginning 2-6 weeks after completion of therapy, patients receive capecitabine 825 mg/m2
orally (PO) twice daily (BID) 5 days a week and undergo radiation therapy 5 days a week for
4 weeks. Patients undergo surgery within 4-10 weeks of completing radiation.Beginning 6-8
weeks after surgery, patients receive gemcitabine IV IV 1000 mg/m2 on days 1, 8, and 15 over
30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the
absence of disease progression or unacceptable toxicity. After completion of study
treatment, patients are followed up every 4 months for 3 years and then periodically
thereafter.

Inclusion Criteria


Pre-Registration Eligibility Criteria

- Documentation of Disease and Radiographic Staging

- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or
uncinate process

- Objective radiographic staging with a) contrast-enhanced, helical thin-cut
computed tomography (CT)/magnetic resonance imaging (MRI) scan of the abdomen
and b) CT scan/MRI of the chest

- Note: echoendoscopic staging will be permitted as an adjunctive modality, but
all stage definitions below will be determined using CT/MRI as outlined below.
In the event echoendoscopic stage and CT/MRI stage are discordant, the CT/MRI
stage will be used. Significant discordance should be discussed with the study
principal investigator (PI) prior to enrollment


- Borderline resectable primary tumor, defined by the presence of any one or more
of the following on CT/MRI, and confirmed by central radiographic review:

- An interface between the primary tumor and the superior mesenteric vein or
portal vein (SMV-PV) measuring ≥ 180 degrees of the circumference of the
vessel wall


- 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

- 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 reconstruction


- An interface between the tumor and superior mesenteric artery (SMA)
measuring < 180 degrees of the circumference of the vessel wall

- No potentially resectable disease defined as primary tumors with all of the
following: 


- An interface between the primary tumor and the superior mesenteric vein or
portal vein (SMV-PV) measuring < 180 degrees of the circumference of the
vessel wall


- No radiographic interface between the tumor and the (superior mesenteric
artery) SMA, hepatic artery or celiac axis


- No radiographic evidence of metastatic disease

- No metastatic disease defined as any one or more of the following:

- Suspicious lymphadenopathy outside the standard surgical field (i.e.,
aortocaval nodes, distant abdominal nodes)


- Radiographic evidence for metastatic disease in distant organs, such as
masses in distant organs or ascites

- No locally advanced and/or unresectable disease clearly defined by any one or
more of the following by CT/MRI:


- An interface between the tumor and the SMA measuring ≥ 180 degrees of the
circumference of the vessel wall


- No interface between the tumor and the aorta


- Occlusion of the SMV or portal vein without a sufficient cuff of normal
vein above and below the level of obstruction with which to perform venous
reconstruction


- Long-segment interface (of any degree) between the tumor and the common
hepatic artery or its major tributaries with insufficient artery proximal
and distal to the interface to perform reconstruction

- No prior chemotherapy or chemoradiation for pancreatic cancer

- No patients with a "currently active" second malignancy other than non-melanoma skin
cancers. Patients are not considered to have a "currently active" malignancy if they
have completed therapy and are free of disease for ≥ 3 years

- Baseline peripheral sensory neuropathy must be grade < 2

- No patients with known Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism

- No history of pulmonary embolism in the past 6 months

- Age ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0-1

- Pregnancy/Nursing Status: Non-pregnant and non-breast-feeding. Female participants of
child-bearing potential must have a negative urine or serum pregnancy test prior to
registration. Perimenopausal participants must be amenorrheic > 12 months to be
considered not of childbearing potential.

- Required Pre-Registration Laboratory Values:

- Granulocytes ≥ 2,000/ul

- Hemoglobin > 9 g/dL

- Platelets ≥ 100,000/ul

- Albumin > 3.0 g/dL

- Creatinine ≤1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase [SGOT]
& alanine aminotransferase (ALT) serum glutamate pyruvate transaminase [SGPT]) ≤
2.5 x ULN

Registration Eligibility Criteria

- Confirmation of pre-registration eligibility criteria as described under
"Documentation of Disease and Radiographic Staging" by the Alliance Central
Radiographic Review

- Required Registration Laboratory Values:

- Bilirubin ≤ 2 mg/dl

- Cancer antigen (CA)19-9 < 1000 U/ml (from time point when bilirubin is ≤ 2
mg/dl)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Accrual rate, calculated by total number of patients accrued divided by number of months from the date the study is opened at the fifth site to the evaluation date

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Matthew Katz, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

A021101

NCT ID:

NCT01821612

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Vanderbilt University/Ingram Cancer CenterNashville, Tennessee  37232