Pancreatic NeoplasmsPhase 2PanFLOXNCT02896803
Fluorouracil and Oxaliplatin as First-line for Advanced Pancreatic Cancer
A Phase 2 study testing mFLOX in people with Pancreatic Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- mFLOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, 01246-000
Tiago Castria, MD PhD, +5511 3893-2000, tiagobiachi@yahoo.com.br
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- mFLOX
- Keywords
- Pancreatic Cancer, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFLOXDrug
Also called 5-fluorouracil and oxaliplatin
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | mFLOX Receives: Drug: mFLOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate will be evaluated according RECIST criteria version 1.1
Measured: Through the study, every 14-16 weeks, until an average of 6 months
Secondary outcomes (3)
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.
Measured: 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
Measured: Through the study, an average of 10 months
Toxicities according CTCAE v4.03
Toxicities will be evaluated every visit, according CTCAE v4.03
Measured: Through the treatment, every visit, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiago Castria, MD PhD, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896803
- Sponsor's protocol ID
- 869/15
- Acronym
- PanFLOX
- Status last verified
- Jul 2020
- First submitted
- 29 Aug 2016
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02896803
- Acronym / sponsor ID
- PanFLOX / 869/15
- Conditions
- Pancreatic Neoplasms
- Keywords
- Pancreatic Cancer, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: mFLOXmFLOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFLOXAlso: 5-fluorouracil and oxaliplatin5-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. | Drug | Experimental |
Primary outcome
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
3 secondary outcomes
Time to progression
Time frame: Through the study, every 14-16 weeks, until an average of 6 months
Overall survival
Time frame: Through the study, an average of 10 months
Toxicities according CTCAE v4.03
Time frame: Through the treatment, every visit, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiago Castria, MD PhD principal investigator
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFLOX in people with Pancreatic Neoplasms, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiago Castria, MD PhD (+55113893-2000, tiagobiachi@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Through the study, every 14-16 weeks, until an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.