Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer

NCT02896803 | Unknown Phase 2

• 1 other identifier: 869/15
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic Cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to progression

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

• Overall survival

  Through the study, an average of 10 months

• Toxicities according CTCAE v4.03

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

Study Arms (1)

Experimental

EXPERIMENTAL

mFLOX

Drug: mFLOX

Interventions

mFLOX DRUG

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.

Also known as: 5-fluorouracil and oxaliplatin

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Tiago Castria, MD PhD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiago Castria, MD PhD

CONTACT

+55113893-2000; tiagobiachi@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 12, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)