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Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

FOLFIRINOX regimen was recently presented at an international oncology meeting and
represents a new standard in the treatment of metastatic pancreatic cancer for selected
patients. With improved overall survival (OS) and response rates (RR) in the metastatic
setting, we hypothesize that in patients with less tumor burden, this regimen will be safe
and well tolerated, improve OS, progression free survival (PFS), and RR, and improve
resectability rates, as compared to historical data from standard single agent gemcitabine
therapy for unresectable locally advanced (ULA) patients and standard radiation with
concurrent 5 flourouracil (5FU) chemotherapy for borderline resectable (BR) patients. While
both ULA and BR patients will be eligible for the present study, our primary objective
concerns ULA patients, and we plan to enroll 45 patients in this group.

Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2
weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI)
every 2 cycles and reassessed for resectability of the tumor. All patients that are not able
to undergo surgical resection, due to insufficient down-staging or patient preference, will
continue on protocol-based therapy until disease progression, unacceptable toxicity, study
withdrawal, or death.

Inclusion Criteria:

- Biopsy confirmed adenocarcinoma of the pancreas.

- Measurable or non-measurable but evaluable (as determined by Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST 1.1]) unresectable locally advanced
(ULA) or borderline resectable (BR) disease that is not amenable to curative intent
therapy. Baseline CT abdomen and chest (or MRI abdomen) within 28 days prior to
initiation of FOLFIRINOX is required.

- ECOG performance status 0 or 1.

- No prior chemotherapy or chemoradiotherapy for pancreatic cancer.

- Age ≥ 18 years of age.

- Laboratory requirements at study entry:

- Hemoglobin ≥ 10 g/dL (transfusions are acceptable)

- ANC ≥ 1.5 x 109/L

- Platelets ≥ 100 x 109/L

- Creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (estimated by
Cockcroft-Gault or measured)

- Total bilirubin ≤ 1.5 x ULN

- AST/ALT ≤ 3 x ULN

- GGT ≤ 5 x ULN

- Life expectancy of at least 6 months.

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test performed within 14 days prior to initiation of FOLFIRINOX.

- WOCBP and men must agree to use adequate contraception prior to study entry, for the
duration of study participation, and 8 weeks after the end of treatment.

- Before patient registration, written informed consent must be given.

Exclusion Criteria:

- Local recurrence or resectable recurrence of pancreatic cancer.

- Other malignancies within the past 3 years except for adequately treated cervical or
vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors
(Ta, Tis & T1). Any cancer curatively treated >3 years prior to entry is permitted.

- Hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to
their excipients. Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment. Patients are not permitted to participate in another investigational
drug study while being treated on this protocol.

- Cardiac disease: Congestive heart failure symptoms > class II NYHA. Unstable angina
(anginal symptoms at rest) or new onset angina beginning within the last 3 months.
Myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias
requiring anti-arrhythmic therapy.

- History of or suspected Gilbert's Disease (baseline testing not required).

- Baseline peripheral neuropathy/paresthesia grade ≥ 1.

- Active hepatitis B, unless patient has been on stable meds for at least 2 months
(baseline testing not required).

- Active clinically serious infections (> grade 2).

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within the 12 weeks prior to the
first dose FOLFIRINOX.

- Evidence or history of bleeding diathesis or coagulopathy. NOTE: If therapeutic
anticoagulation required, the investigator is encouraged to switch patient to (or
maintain on) low molecular weight heparin during the trial.

- Major surgery, open biopsy or significant traumatic injury within 8 weeks of first
study drug. A core pancreatic or liver biopsy does not preclude the patient from the

- Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of
CYP3A4 enzyme-inducing drugs and strong CYP3A4 inhibitors is discouraged, but not

- Active drug or alcohol abuse.

- Pregnant or lactating women.

- Psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule; those conditions should be
discussed with the patient before registration in the trial.

Type of Study:


Study Design:

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

Outcome Measure:

Median overall survival (OS) of FOLFIRINOX in patients with unresectable locally advanced (ULA) pancreatic cancer

Outcome Description:

All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Autumn J McRee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina


United States: Institutional Review Board

Study ID:

LCCC 1105



Start Date:

January 2012

Completion Date:

February 2016

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic
  • Phase II
  • Unresectable
  • Regimen
  • First-line
  • Resectable
  • Borderline
  • Oxaliplatin
  • Leucovorin
  • Irinotecan
  • 5FU
  • Lineberger
  • University of North Carolina
  • Pancreatic Neoplasms



Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599-7305