Fluorouracil And Oxaliplatin As First-line For Advanced Pancreatic Cancer

Study Overview

Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer

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.

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.

Pancreatic Neoplasms

DRUG: mFLOX

869/15

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-08-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-11-09
First Submitted that Met QC Criteria 2016-09-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-11-10
First Posted (ACTUAL) 2016-09-12	Results First Posted N/A	Last Verified 2020-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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.

Participant Group/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.

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

Secondary Outcome Measures	Measure Description	Time Frame
Time to progression	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.	Through the study, every 14-16 weeks, until an average of 6 months
Overall survival	It is defined as a time between entry in the trial and death	Through the study, an average of 10 months
Toxicities according CTCAE v4.03	Toxicities will be evaluated every visit, according CTCAE v4.03	Through the treatment, every visit, an average of 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tiago Castria, MD PhD

Phone Number: +55113893-2000

Email: tiagobiachi@yahoo.com.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Tiago Castria, MD PhD, Instituto do Cancer do Estado de São Paulo

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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