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

Who is this study for? Patients with Metastatic Pancreatic Cancer
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female aged 18 to 75 on the date the consent is signed.

• 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.

• 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).

• Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected.

• WHO performance status ≤ 1

• Uracilemia \<16 ng / ml

• 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.

• 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).

• Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN

⁃ 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.

⁃ Signature of consent before any procedure specific to the study.

⁃ Affiliated with the French national social security.

Locations
Other Locations
France
Centre Georges-François Leclerc
RECRUITING
Dijon
CHU Grenoble
NOT_YET_RECRUITING
Grenoble
CHU St Eloi
RECRUITING
Montpellier
Institut régional du Cancer de Montpellier
RECRUITING
Montpellier
Centre Catalan d'Oncologie
NOT_YET_RECRUITING
Perpignan
CH de Perpignan
RECRUITING
Perpignan
Institut GODINOT
RECRUITING
Reims
CHU St Etienne
ACTIVE_NOT_RECRUITING
Saint-etienne
Contact Information
Primary
Aurore MOUSSION, MD
Aurore.Moussion@icm.unicancer.fr
0467612446
Backup
Fabienne PORTALES, MD
Fabienne.Portales@icm.unicancer.fr
0467612353
Time Frame
Start Date: 2022-01-11
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 162
Treatments
Experimental: GEMBRAX/FOLFIRINOX Arm A
One cycle:~* D1, D8 and D15 GEMBRAX: Albumin bound paclitaxel 125mg / m² followed by Gemcitabine 1000mg / m² followed by 2 weeks of rest~* D29 and D43 FOLFIRINOX: Oxaliplatin 85mg / m², Irinotecan 180mg / m², Folinic acid 400 mg / m², 5-fluorouracil 400mg / m² in bolus followed by continuous administration over 46h at 2400mg / m² followed by 2 weeks of rest.~A maximum of 6 cycles (12 months) of chemotherapy will be administered to patients in arm A.
Active_comparator: FOLFIRINOX Arm B
One cycle :~D1, D15, D29 and D43 FOLFIRINOX: Oxaliplatin 85mg / m², Irinotecan 180mg / m², Folinic acid 400mg / m², 5-fluorouracil 400mg / m² as a bolus followed by continuous administration over 46h at 2.400mg / m² followed by 2 weeks of rest.~A maximum of 3 cycles (6 months) of chemotherapy will be administered to patients in arm B.
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov

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