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

Launched by INSTITUT DU CANCER DE MONTPELLIER - VAL D'AURELLE · Oct 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with metastatic pancreatic cancer, which means the cancer has spread from the pancreas to other parts of the body. The researchers want to see if using a combination of two treatments—first Gembrax (which includes Gemcitabine and Abraxane) followed by Folfirinox (a combination of four medications)—is more effective than using Folfirinox alone. This trial is currently looking for participants aged 18 to 75 who have been diagnosed with metastatic pancreatic adenocarcinoma and have measurable tumors.

To be eligible, participants must have had a previous diagnosis of non-metastatic pancreatic cancer but are now facing a recurrence. They should not have any serious health issues that could interfere with the study, such as major heart problems or certain other cancers. If you or a loved one is considering joining this trial, you can expect close monitoring and care throughout the treatment process, and participants will be asked to agree to contraception if they are sexually active. It’s important to discuss any questions or concerns with your doctor to determine if this trial is a good fit.

Gender

ALL

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. History of chronic inflammatory disease of the colon or rectum
• • 10. 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)
• • 11. Intolerance or allergy to one of the study drugs (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (example: fructose) described in the sections Against SPC indications or Special Warnings and Precautions or Prescribing Information
• • 12. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test (serum β-hCG) within 72 hours prior to inclusion.
• • 13. Patients on anticoagulants (e.g., Coumadin) (modifications to treatment may be required prior to inclusion).
• • 14. Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction).
• • 15. Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment.
• • 16. Active HIV infection, known hepatitis B or C infection.
• • 17. History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia.
• • 18. Administration of a live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment.
• • 19. Patient refusal or inability to comply with study procedures.
• • 20. Inability to undergo follow-up for geographical, social, or psychological reasons.
• • 21. Participation in another clinical trial involving an investigational product within the 30 days prior to inclusion.
• • 22. Legal incapacity (patient under guardianship or guardianship).