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A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01660711
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Robert de W Marsh MD, NorthShore University HealthSystem

Brief Summary:
The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: 5 Fluorouracil Drug: Leucovorin Drug: Irinotecan Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Neoadjuvant and Adjuvant mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma
Study Start Date : July 2012
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Leucovorin

Arm Intervention/treatment
Experimental: FOLFIRINOX chemotherapy

5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1

Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery.

Drug: 5 Fluorouracil
2400 mg/m2 by continuous intravenous infusion over 46 hours
Other Name: Adrucil,5FU

Drug: Leucovorin
400 mg/m2 by IV infusion over 2 hours
Other Name: Folinic acid, Wellcovorin, citrovorum factor

Drug: Irinotecan
180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)
Other Name: camptosar, CPT11

Drug: Oxaliplatin
85 mg/m² IV infusion on Day 1 over 2 hours
Other Name: Eloxatin,




Primary Outcome Measures :
  1. Percentage able to complete full course of preoperative chemotherapy [ Time Frame: Following completion of all planned therapy, an expected average of 4 months ]

    The percentage of patients able to complete the full course of preoperative chemotherapy and undergo a resection. This will be the primary determinant of success for this pilot study.

    Early withdrawals due to toxicity, disease progression, or intercurrent illness will be considered failures.



Secondary Outcome Measures :
  1. Percentage able to complete full course of therapy [ Time Frame: On completion of all planned therapy, an expected average of 8 months ]
    The percentage of patients able to complete the full course of therapy, including preoperative chemotherapy, surgical resection and postoperative chemotherapy.


Other Outcome Measures:
  1. Treatment related toxicity [ Time Frame: 1 year ]
    Treatment related toxicity and other adverse events (AEs) during Toxicity of preoperative and postoperative therapy and the safety of this approach.

  2. R0 resection rate [ Time Frame: 3 months ]
    Assessment of the percentage of patients able to have an R0 resection following preoperative chemotherapy.

  3. Progression-free and overall survival [ Time Frame: 5 years ]
    Assessment of progression-free survival and overall survival from the start of study treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.
  • Resectable primary tumor of the head, body or tail of the pancreas defined as a visible mass in the pancreas and:
  • No extrapancreatic disease
  • A patent superior mesenteric (SMV)- portal vein (PV) confluence (assuming the technical ability to resect and reconstruct this venous confluence if needed)
  • A definable tissue plane between the tumor and regional arterial structures including the celiac axis, common hepatic artery, and SMA.
  • Confirmation of resectability by surgical oncology consultation.
  • Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University
  • No previous therapy for pancreatic cancer
  • Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice
  • Karnofsky performance status 80 or better
  • Age > 21 years
  • No currently active second malignancy
  • No CVA within 6 months, no MI within 6 months
  • The effects of mFOLFIRINOX on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Negative pregnancy test in females of reproductive age
  • Life expectancy of greater than 3 months.
  • Anticoagulation is permitted but patients may only be on lovenox for this purpose.
  • Patients must have normal organ and marrow function as defined below:

    • absolute neutrophil count >1,500/mcL
    • platelets >100,000/mcL
    • total bilirubin <1.5X upper limits of normal
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance >60 mL/min/ per Cockcroft-Gault equation for patients with creatinine levels above institutional normal.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
  • Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
  • Patients who are receiving any investigational agents.
  • Patients with borderline resectable, locally advanced or metastatic disease.
  • History of allergic reactions attributed to 5FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active liver disease including viral or non-viral hepatitis and cirrhosis, chronic diarrhea or inflammatory disease of the colon or rectum, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study. mFOLFIRINOX is a regimen containing more than one chemotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with FOLFIRINOX, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with mFOLFIRINOX. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years.
  • Pre-existing neuropathy greater than grade 1.
  • Anticoagulants other than low molecular weight heparin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660711


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
University of Chicago
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Responsible Party: Robert de W Marsh MD, Section Chief Gastrointestinal Oncology, Clinical Professor University of Chicago, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01660711    
Other Study ID Numbers: EH12-267
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by Robert de W Marsh MD, NorthShore University HealthSystem:
neoadjuvant
chemotherapy
resectable
adjuvant
pancreas
cancer
adenocarcinoma
surgery
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Fluorouracil
Oxaliplatin
Irinotecan
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances