Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer (PanFLOX)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02896803
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Brief Summary:
Patients with locally advanced or metastatic pancreatic adenocarcinoma not eligible for infusional fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) (PPS 2 or hyperbilirubinemia, among other causes) will be treated with mFLOX regimen (fluorouracil bolus and oxaliplatin). The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: mFLOX Phase 2

Detailed Description:

Currently, FOLFIRINOX is considered the standard treatment for PS 0 or 1 patients with advanced pancreatic carcinoma. However, due to excessive toxicity dose reductions and interruptions in the treatment toxicity are frequent. So, for those not eligible patients (PS 2 or 3, hyperbilirubinemia, among other causes), alternative schemes as gemcitabine alone are the standard approach .

This study aims to evaluate the efficacy and safety of the mFLOX regimen (fluorouracil bolus and oxaliplatin) as first-line regimen for advanced pancreatic adenocarcinoma not eligible for FOLFIRINOX.

The primary endpoint is to assess the objective response rate according to RECIST criteria (version 1.1) and the secondary endpoints are time until clinical or radiological progression, overall survival, toxicity profile.

It has been estimated an n=34 for a response rate of 20%, compared to the historical control of 7% with gemcitabine alone (Von Hoff et al.), with an alpha error of 5% and power of 80%. Considering a rate of 10% of dropout, our sample will be 37 patients.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Bolus Fluorouracil and Oxaliplatin (mFLOX) as First-line Regimen for Patients With Unresectable or Metastatic Pancreatic Cancer Not Eligible for Infusional Fluorouracil, Irinotecan and Oxaliplatin
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
mFLOX
Drug: mFLOX
5-fluorouracil 500 mg/m2 and folinic acid 20 mg/m2 infused both bolus weekly for 6 weeks (d1, 8,15, 22, 29 and 36) and oxaliplatin 85 mg / m2 infused over 2 hours at weeks 1,3 and 5 (d1,15 and 29). The scheme will be repeated every 8 weeks.
Other Name: 5-fluorouracil and oxaliplatin




Primary Outcome Measures :
  1. Response rate [ Time Frame: Through the study, every 14-16 weeks, until an average of 6 months ]
    Response rate will be evaluated according RECIST criteria version 1.1


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Through the study, every 14-16 weeks, until an average of 6 months ]
    CT scans will be performed every 14-16 weeks, until disease progression (according to RECIST criteria version 1.1) or death, an average of 6 months.

  2. Overall survival [ Time Frame: Through the study, an average of 10 months ]
    It is defined as a time between entry in the trial and death

  3. Toxicities according CTCAE v4.03 [ Time Frame: Through the treatment, every visit, an average of 6 months ]
    Toxicities will be evaluated every visit, according CTCAE v4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pancreatic adenocarcinoma, confirmed by biopsy and histological material available for review
  • Unresectable primary tumor considered by the team assistant or metastatic disease
  • Aged between 18 and 75 at the time of study entry
  • Naïve patients of palliative chemotherapy, admitted for treatment at the Institute of the São Paulo State Cancer (ICESP)
  • Patients with performance status 0 or 1, not candidates to receive chemotherapy with FOLFIRINOX or performance status 2.
  • No significant organ dysfunction defined as: Hb> 9 g / dL, platelets> 100,000 / microliter (mcL), neutrophils> 1500 / mcL, clearance of creatinine (ClCr) > 50 ml / min, total bilirubin <5 mg/dl, serum alanine transaminase (ALT) and aspartate transaminase (AST) <2.5 x upper limit of normal (ULN) (or <5 x ULN if liver metastases present)
  • Able to read and sign an informed consent form.

Exclusion Criteria:

  • Use of prior chemotherapy with other agents, except adjuvant chemotherapy with gemcitabine monotherapy since completed more than 6 months
  • Absence of histological material available to local review (eg diagnostic fine needle aspiration (FNA) or cytology)
  • Previous use of radiotherapy in the primary tumor or a metastasis site that will serve as target lesion to assess response to treatment
  • Diagnosis of malignancy other activity except non-melanoma skin cancer
  • Clinical evidence of metastasis in the central nervous system active meningeal carcinomatosis or severe chronic disease patients (cirrhosis, heart failure New York Heart Association Functional Classification (NYHA) III or IV, chronic obstructive pulmonary disease (COPD) oxygen-dependent or chronic kidney disease requiring dialysis)
  • Pregnant or breastfeeding
  • Patients with HIV / AIDS story on anti-retroviral therapy
  • Patients with peripheral neuropathy grade> 2 (CTCAE v4.03)
  • Medium or large surgery in the last 4 weeks. For example, biliary derivation.

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): NCT02896803


Contacts
Layout table for location contacts
Contact: Tiago Castria, MD PhD +55113893-2000 tiagobiachi@yahoo.com.br

Locations
Layout table for location information
Brazil
Instituto do Câncer do Estado de São Paulo Recruiting
São Paulo, Brazil, 01246-000
Contact: Tiago Castria, MD PhD    +5511 3893-2000    tiagobiachi@yahoo.com.br   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
Layout table for investigator information
Principal Investigator: Tiago Castria, MD PhD Instituto do Cancer do Estado de São Paulo

Layout table for additonal information
Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT02896803     History of Changes
Other Study ID Numbers: 869/15
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Pancreatic Cancer
Chemotherapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs