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

Primary Purpose

Pancreatic Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

mFLOX

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic Cancer, Chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto do Câncer do Estado de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

mFLOX

Outcomes

Primary Outcome Measures

Response rate

Response rate will be evaluated according RECIST criteria version 1.1

Secondary Outcome Measures

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.

Overall survival

It is defined as a time between entry in the trial and death

Toxicities according CTCAE v4.03

Toxicities will be evaluated every visit, according CTCAE v4.03

Full Information

NCT ID

NCT02896803

First Posted

August 29, 2016

Last Updated

November 9, 2020

Sponsor

Instituto do Cancer do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02896803

Brief Title

Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer

Acronym

PanFLOX

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 Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto do Cancer do Estado de São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

Keywords

Pancreatic Cancer, Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

mFLOX

Intervention Type

Drug

Intervention Name(s)

mFLOX

Other Intervention Name(s)

5-fluorouracil and oxaliplatin

Intervention Description

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 Measure Information:

Title

Response rate

Description

Response rate will be evaluated according RECIST criteria version 1.1

Time Frame

Through the study, every 14-16 weeks, until an average of 6 months

Secondary Outcome Measure Information:

Title

Time to progression

Description

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.

Time Frame

Through the study, every 14-16 weeks, until an average of 6 months

Title

Overall survival

Description

It is defined as a time between entry in the trial and death

Time Frame

Through the study, an average of 10 months

Title

Toxicities according CTCAE v4.03

Description

Toxicities will be evaluated every visit, according CTCAE v4.03

Time Frame

Through the treatment, every visit, an average of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tiago Castria, MD PhD

Phone

+55113893-2000

tiagobiachi@yahoo.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiago Castria, MD PhD

Organizational Affiliation

Instituto do Cancer do Estado de São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto do Câncer do Estado de São Paulo

City

São Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tiago Castria, MD PhD

Phone

+5511 3893-2000

tiagobiachi@yahoo.com.br

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer

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