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Recruiting Phase 2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2022-01-11
Last updated
2026-04-15

Condition(s) studied

Metastatic Pancreatic Cancer

Investigational drug(s) / intervention(s)

GEMBRAX/FOLFIRINOX Arm AFOLFIRINOX Arm B

GEMBRAX/FOLFIRINOX Arm A: Patients in the experimental arm received sequential treatment: A maximum of 6 cycles (12 months) of chemotherapy; One cycle = 3 administrations of GEMBRAX followed by 2 administrations of FOLFIRINOX

FOLFIRINOX Arm B: Patients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX

Study summary

The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female aged 18 to 75 on the date the consent is signed. 2. Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data. 3. One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast). 4. Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected. 5. WHO performance status ≤ 1 6. Uracilemia \<16 ng / ml 7. Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by: • Neutrophils ≥ 2 × 109 / L; • Platelets ≥ 100,000 / mm3 (100 × 109 / L); • Hemoglobin ≥ 9 g / dl. 8. Acceptable renal and hepatic function at inclusion (obtained within 14 days before the start of treatment) defined by: • AST and ALT ≤ 2.5 x upper limit of the norm (ULN), unless liver metastases are present in this case AST and ALT ≤ 5 × ULN is allowed; • Total bilirubin ≤ 1.5 x ULN; • Serum creatinine within the norm limits or calculated clearance ≥ 50ml / min for patients with a serum creatinine value above or below the norm values (clearance calculated by the CKD-EPI formula). 9. Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN 10. If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of administration of the study drug and up to 6 months after discontinuation of treatment for women and for men. 11. Signature of consent before any procedure specific to the study. 12. Affiliated with the French national social security. Exclusion Criteria: 1. Known brain metastasis. 2. Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease. 3. Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment. 4. Known Gilbert's syndrome or homozygous for know UGT1A1 \* 28 5. Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated curatively without chemotherapy and without any sign of disease in the 3 years preceding inclusion. 6. Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months. 7. Peripheral sensory neuropathy ≥ grade 2 at the time of inclusion. 8. ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women 9. Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders) 10. Allergy or intolerance to any study drug (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or any excipient (e.g., fructose) as described in the sections " contraindication or special warnings and precautions" or "prescribing information" of the summary of product characteristics indications. 11. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test (serum β-hCG) within 72 hours prior to inclusion. 12. Patients on vitamin K antagonists (e.g., Coumadin) (modifications to treatment may be required prior to inclusion). 13. Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction). 14. Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment. 15. Active HIV infection, known hepatitis B or C infection. 16. History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia. 17. Administration of a live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment. 18. Patient refusal or inability to comply with study procedures. 19. Inability to undergo follow-up for geographical, social, or psychological reasons. 20. Participation in another clinical trial involving an investigational product within the 30 days prior to inclusion. 21. Legal incapacity (patient under guardianship or guardianship).

Primary outcome measure(s)

  • Progression-free survival — From randomization to disease progression or death, up to 6 month
    To compare progression-free survival between the investigational treatment (Arm A) and the standard treatment (Arm B) in patients with metastatic 1st line pancreatic adenocarcinoma. Progression-free survival defined as the time between randomization and the onset of the 1st documented progression or death from any cause. Tumor progression is assessed according to the RECIST 1.1 criteria and by the centralized review.

Trial sites (8)

FacilityCityRegionStatus
CHU Grenoble Grenoble Auvergne-Rhône-Alpes Not Yet Recruiting
CHU St Etienne Saint-Etienne Auvergne-Rhône-Alpes Active Not Recruiting
Institut GODINOT Reims Grand Est Recruiting
CHU St Eloi Montpellier Herault Recruiting
Institut régional du Cancer de Montpellier Montpellier Hérault Recruiting
Centre Catalan d'Oncologie Perpignan Pyrénées-Orientales Not Yet Recruiting
CH de Perpignan Perpignan Pyrénées-Orientales Recruiting
Centre Georges-François Leclerc Dijon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05065801 on ClinicalTrials.gov ↗ ← All trials in France