FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

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Brief Title

FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

Official Title

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

Brief Summary

      This single arm, multi-center phase II clinical trial will assess the safety and efficacy of
      FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and
      borderline resectable (BR) pancreatic cancer.
    

Detailed Description

      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
      fluorouracil (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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer

Secondary Outcome

 Overall Survival for Borderline Resectable Patients

Condition

Pancreatic Cancer

Intervention

FOLFIRINOX

Study Arms / Comparison Groups

 FOLFIRINOX
Description:  FOLFIRINOX given to all subjects

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

January 2012

Completion Date

November 22, 2016

Primary Completion Date

August 22, 2016

Eligibility Criteria

        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.

          -  Eastern Cooperative Oncology Group (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)

               -  absolute neutrophil count (ANC) ≥ 1.5 x 109/L

               -  Platelets ≥ 100 x 109/L

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

               -  Total bilirubin ≤ 1.5 x ULN

               -  aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) ≤ 3 x ULN

               -  Gamma-Glutamyl Transferase (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 New York Heart
             Association (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
             study.

          -  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
             contraindicated.

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Autumn J McRee, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01688336

Organization ID

LCCC 1105


Responsible Party

Sponsor

Study Sponsor

UNC Lineberger Comprehensive Cancer Center


Study Sponsor

Autumn J McRee, MD, Principal Investigator, University of North Carolina


Verification Date

September 2017