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First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem (PANOPTIMOX)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352337
Recruitment Status : Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Tracking Information
First Submitted Date  ICMJE January 14, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date March 30, 2020
Actual Study Start Date  ICMJE December 23, 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
Rate of patients alive and without radiological and/or clinical progression [ Time Frame: 6 months after randomization ]
Progression is defined as radiological (RECIST v1.1) and/or clinical according to the investigator. Progression or death (whatever the reason is) will be taking into account if the event occurs during the 6 first months of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
the patient rate in live and without radiological and or clinical progression at 6 months after randomization [ Time Frame: 6 months after randomization ]
Progression is defined as radiological (RECIST v1.1) and/or clinical according to the investigator. Progression or death (whatever the reason is) will be taking into account if the event occurs during the 6 first months of treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Duration of disease control [ Time Frame: After randomisation ]
  • Toxicity (NCI-CTC V4.0) [ Time Frame: After randomisation ]
  • Time to progression during the maintenance of treatment [ Time Frame: After randomization ]
  • Overall survival [ Time Frame: 2 years ]
  • Progression survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • Duration of desease control [ Time Frame: 2 years after the last patient randomized ]
  • Toxicity (NCI-CTC V4.0) [ Time Frame: 2 years after the last patient randomized ]
  • Quality of live (QLQ-C30) [ Time Frame: 2 years after the last patient randomized ]
  • Time to progression during the maintenance of treatment [ Time Frame: 2 years after the last patient randomized ]
  • Overall survival [ Time Frame: 2 years after the last patient randomized ]
  • Progression survival [ Time Frame: 2 years after the last patient randomized ]
  • Patient rate receiving 2de line of treatment [ Time Frame: 2 years after the last patient randomized ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem
Official Title  ICMJE Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line
Brief Summary

The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy.

Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin.

These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.

FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment.

The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Drug: FOLFIRINOX
    Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue
  • Drug: LV5FU2
    Perfusion: Folinic Acid,5FU Bolus,5FU continue
  • Drug: FOLFIRI.3
    Perfusion :Irinotecan,Acide folinique ,5FU continue
  • Drug: Gemcitabine
    Gemcitabine perfusion
Study Arms  ICMJE
  • Active Comparator: FOLFIRINOX
    Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours
    Intervention: Drug: FOLFIRINOX
  • Experimental: FOLFIRINOX + LV5FU2 in maintenance

    Folfirinox during 4 months followed by LV5FU2 maintenance until progression:

    Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours.

    Interventions:
    • Drug: FOLFIRINOX
    • Drug: LV5FU2
  • Experimental: FIRGEM

    Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE:

    Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over

    Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest )

    Interventions:
    • Drug: FOLFIRI.3
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 28, 2015)
276
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic disease
  • At least one mesurable lesion according to RECIST V1.1 criteria
  • No prior chemotherapy (excepted if there is at least on lestion out of the irradition area)
  • Age > 18 years. A favorable adviced by an onco geriatrician would be mandatory for inclusion of patients older than 75 older
  • Performance statut (WHO) 0-1
  • Polynyclear ≥ 1500/mm3
  • Bilirubine ≤ 1,5 fois la LSN, creatinin < 120μmol / L
  • Signed informed consent form

Exclusion Criteria:

  • Another type of pancreas tumor, as endocrine tumor ou with acinous cells
  • Ampulloma
  • Cerebral or meningeal metastasis
  • Gilbert disease
  • Neuropathie > or = grade 1
  • Study treatments contraindication
  • Uncontrolled diarrhoea or inflamatory disease of colon or rectum, or bowel obstruction or bowel sub-obstruction no resolved with specific treatment
  • Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease prevent patient to receive study Cancer within the 5 years before inclusion, except for int situ cancer of the neck of the uterus or basal cell skin cancer
  • Significant previous cardiac and respiratory disease
  • Patient included in an other therapeutic study with experimental treatment
  • Pregnancy or breast feeding
  • Patient depreved of freedom or under gardianship
  • Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02352337
Other Study ID Numbers  ICMJE PRODIGE35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Federation Francophone de Cancerologie Digestive
Study Sponsor  ICMJE Federation Francophone de Cancerologie Digestive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: DAHAN Laetitia, MD MARSEILLE La Timone
PRS Account Federation Francophone de Cancerologie Digestive
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP