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Completed

NCT Number: NCT02827201

FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinique Privée Claude Bernard, Albi, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological or cytological confirmation of pancreatic adenocarcinoma
  • Distant metastatic disease
  • Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
  • At least one lesion measurable by RECIST v1.1 criteria
  • Life expectancy> 3 months
  • No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
  • No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
  • Pain must be monitored before inclusion
  • 18 years < age < 75
  • Performance status: WHO < 2
  • ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
  • ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
  • Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
  • Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
  • Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
  • Patient affiliated to the social security scheme
  • Patient information and signature of informed consent

Exclusion criteria

  • - Other types of pancreatic tumours, especially endocrine or acinar cell tumours
  • Ampulloma
  • Presence of meningeal or cerebral metastases, bone metastases
  • Gilbert's syndrome
  • Presence of neuropathy> grade 1 according to NCIC-CTC 4.0
  • Contraindications specific to the studied treatments
  • History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
  • Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
  • Significant history of heart or respiratory disease, including any history of interstitial pneumonia
  • Patient already included in another clinical trial with an experimental molecule
  • Women who are breast-feeding
  • Persons deprived of liberty or under guardianship
  • Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons

Treatment and study plan

FOLFIRI.3

Drug

For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)

nab-paclitaxel+ gemcitabine

Drug

For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Primary outcomes

  1. Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization

    Time frame: 6 months after randomization

    The primary endpoint was the rate of patients alive and progression-free 6 months after randomization.

    Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites.

    Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months.

    The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.

Secondary outcomes

  1. Overall Survival (OS):

    Time frame: Up to 2 years after the treatment start

    Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account

  2. Best Response

    Time frame: Up to the end of treatment on the average of 12 months

    Best response is defined as the best response for each patient regarding imagerie taken during the treatment. Response was evalauted according to RECIST v1.1 over the entire treatment period according the investigator

  3. Progression-free Survival (PFS)

    Time frame: up to 12 months after randomization

    It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news

Sponsors and collaborators

Lead sponsor

Federation Francophone de Cancerologie Digestive

Other

Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group
  • UNICANCER

Registry information

Official study title

Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer

Acronym: FIRGEMAX

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Jul 11, 2016
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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