Comparing Gembrax followed by Folfirinox to Folfirinox alone for metastatic pancreatic cancer

Randomized Phase II Trial Evaluating the Efficacy of a Sequential Treatment Gemcitabine Plus Nab-paclitaxel (Gembrax) Followed by Folfirinox Versus Folfirinox Alone in Patients Treated in First Metastatic Line Pancreatic Cancer

This study is testing if a new treatment combining Gembrax and Folfirinox can help people with metastatic pancreatic cancer live longer and feel better compared to just using Folfirinox alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Grenoble, Auvergne-Rhône-Alpes and 7 other locations)
• Trial ID: NCT05065801 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a sequential treatment approach using Gembrax, which includes Gemcitabine and Abraxane, followed by the Folfirinox regimen in patients with first-line metastatic pancreatic cancer. The trial will compare this combination treatment to Folfirinox alone to determine if the sequential approach offers improved outcomes. Patients will be monitored for overall survival, progression-free survival, and response rates. The study is designed to provide insights into potential new treatment strategies for a condition with historically poor prognosis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with histologically confirmed metastatic pancreatic adenocarcinoma and measurable metastatic lesions.

Not a fit: Patients with a performance status greater than 1 or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could lead to improved survival rates and better quality of life for patients with metastatic pancreatic cancer.

How similar studies have performed: Previous studies have shown promising results with Folfirinox as a standard treatment, but the sequential use of Gembrax followed by Folfirinox is a novel approach that has not been extensively tested.

Eligibility criteria

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).

Where this trial is running

Grenoble, Auvergne-Rhône-Alpes and 7 other locations

• CHU Grenoble — Grenoble, Auvergne-Rhône-Alpes, France (Not_yet_recruiting)
• CHU St Etienne — Saint-Etienne, Auvergne-Rhône-Alpes, France (Active_not_recruiting)
• Institut GODINOT — Reims, Grand Est, France (Recruiting)
• CHU St Eloi — Montpellier, Herault, France (Recruiting)
• Institut régional du Cancer de Montpellier — Montpellier, Hérault, France (Recruiting)
• Centre Catalan d'Oncologie — Perpignan, Pyrénées-Orientales, France (Not_yet_recruiting)
• CH de Perpignan — Perpignan, Pyrénées-Orientales, France (Recruiting)
• Centre Georges-François Leclerc — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Aurore MOUSSION, MD

Conditions Metastatic Pancreatic Cancer; pancreatic; cancer