A Study of Administering FOLFIRINOX Before Surgery For Potentially Curable Pancreatic Cancer

NCT03167112 | Unknown Phase 2

• 1 other identifier: CODIM-MBM-17-040
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is a serious condition and is one of the leading cause of cancer related health problem. It is estimated that in 2016, 5,200 Canadians will be diagnosed with pancreatic cancer, and approximately 20% (1 in 5) of patients will have localized cancer (cancer that is limited to pancreas and there is no evidence of cancer in other parts of the body). Localized cancer is earlier stage of disease and surgery to remove the cancer is standard of care in this condition. However, recent scientific and clinical studies show that using the chemotherapy medication before surgery can improve the overall survival in patents with localized pancreatic cancer. One of these chemotherapy regimen is combination of fluorouracil, oxaliplatin, irinotecan, leucovorin (FOLFIRINOX) that we are going to evaluate its effect in this study. Because of promising result of this combination in more advanced stage of pancreatic cancer, this study is going to examine its efficiency in earlier stage of pancreatic cancer (localized form). Total number of participant in this study will be 20 patients with localized form of pancreatic cancer without any evidence of cancer in other parts of the body. Laboratory tests show that it works by slowing down the growth of cancer or may cause cancer cells to die. It is hoped that by shrinking the tumor size, the surgeon will be able to remove the cancer and improve the overall survival. Procedures start with 2 weeks of comprehensive evaluation. Approximately 20 eligible subjects, based on this study criteria, will receive 6 treatment of this regimen every 2 weeks. Once 6 treatments have been completed, comprehensive re-evaluation procedures will be repeated, and subjects without disease progression or unacceptable toxicity will continue on their treatment based on treating team decision (surgical intervention, radiation therapy or continue FOLFIRINOX or different regimen). Patients then will follow with CT scan, blood test and physical examination every 3 months.

Conditions

Pancreatic Cancer

Keywords

Potentially Curable; Preoperative; FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• Time to Progression (TTP).

  Time to Progression (TTP) is defined as the time from the first cycle of chemotherapy until objective tumor progression.

  Through study completion, an average of 1 year.

Secondary Outcomes (4)

• Overall Response Rate

  Through study completion, an average of 1 year

• Residual (R) tumor status

  Through study completion, an average of 1 year.

• Incidence of Treatment related Adverse Events [Safety and Tolerability]

  Through study completion, an average of 1 year.

• Overall survival (OS)

  Through study completion, an average of 1 year

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL

Oxaliplatin, Irinotecan, Leucovorin, Fluorouracil

Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil

Interventions

Oxaliplatin DRUG

Patients receive Oxaliplatin 85 mg/m2 over 2 hours.

Also known as: Study regimen

FOLFIRINOX

Irinotecan DRUG

Oxaliplatin is followed by Irinotecan (CPT-11) 180 mg/m2 over 90 min.

Also known as: Study regimen

FOLFIRINOX

Leucovorin DRUG

Oxaliplatin and Irinotecan is followed by Leucovorin (LV) 400 mg/m2 over 2 hours day1

Also known as: Study regimen

FOLFIRINOX

Fluorouracil DRUG

Oxaliplatin and Irinotecan and Leucovorin is followed by Fluorouracil (5-FU) 400 mg/m2 bolus day1 and 2,400 mg/m2 46h continuous infusion.

Also known as: Study regimen

FOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• ≥ 18 years of age at the time of signing the informed consent form.
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures conducted.
• Histologically or cytologically confirmed adenocarcinoma of the pancreas.
• Performance status or Comorbidity condition not currently appropriate (but potentially reversible) for a major abdominal operation.
• Acceptable hematology parameters:
• Absolute neutrophil count (ANC) ≥ 1500 cell/mm3
• Platelet count ≥ 100,000/mm3 without transfusion support.
• Hemoglobin (Hgb) ≥ 9 g/dL
• Acceptable blood chemistry levels:
• Hepatic transaminases (ALT and AST) less than 2.5× the upper limits of normal (ULN)
• Total bilirubin level less than 1.5 × the upper limits of normal (ULN) or in patient with Biliary stenting less than 2 mg/dL
• Serum creatinine level less than 1.5 × the upper limits of normal (ULN) or creatinine clearance (Ccr) ≥ 40 mL/min.
• Alkaline phosphatase ≤ 2.5 x ULN
• Serum albumin \> 3 g/dL

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Pancreatic tumors of endocrine or mixed origin.
• Prior anticancer therapy for pancreatic carcinoma.
• Presence of or history of metastatic pancreatic adenocarcinoma.
• Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the prostate (Gleason score ≤ 7), cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment).
• Active bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
• Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelo-suppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications.
• History of allergy or hypersensitivity to study regimen or any of their excipients.
• Peripheral sensory neuropathy Grade \> 1.
• Clinically significant ascites.
• Plastic biliary stent. (Metal biliary stent is allowed.)
• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the integrity of the study data. These include, but are not limited to:
• History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa)
• History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or multiple allergies
• History of the following within 6 months prior to treatment 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder

Sponsors & Collaborators

• Petr Kavan: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Irinotecan; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Petr Kavan, MD, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Kavan, MD, PhD

CONTACT

+1-514340-8222; petr.kavan@mcgill.ca

Hamed Javan, MD

CONTACT

+1-514340-8222; hamed.javan@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Petr Kavan,Director,AYA Oncology,Associate Professor,Dept. of Oncology

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 25, 2017
• Study Start: July 3, 2017
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

CA (1)