A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically proven metastatic adenocarcinoma of the pancreas
• Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy
• Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration
• Peripheral Neuropathy \< grade 2
Locations
Other Locations
Belgium
UZ Antwerpen
RECRUITING
Antwerp
AZ Imelda
RECRUITING
Bonheiden
AZ St-Lucas
NOT_YET_RECRUITING
Bruges
Cliniques Universitaires Saint-Luc UCL
RECRUITING
Brussels
ULB Erasme
RECRUITING
Brussels
Grand Hopital de Charleroi
RECRUITING
Charleroi
AZ Maria Middelares
RECRUITING
Ghent
University Hospital Ghent
RECRUITING
Ghent
Pôle Hospitalier Jolimont (HELORA)
RECRUITING
Haine-saint-paul
CHC MontLégia
RECRUITING
Liège
CHU Ambroise Paré
RECRUITING
Mons
CHR Namur
RECRUITING
Namur
AZ Turnhout
RECRUITING
Turnhout
Contact Information
Primary
Lina Dewever
lina.dewever@bgdo.org
+32 (0) 479 36 63 82
Time Frame
Start Date:2022-05-25
Estimated Completion Date:2027-12-31
Participants
Target number of participants:134
Treatments
Active_comparator: Arm A NALIRI
Cycle length: 14 days~Day 1:~* Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours~* Liposomal irinotecan (FBE): 70 mg/m² IV\* - Dilute in 500 mL DSW and administer over 90 min~* 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS.~ * Patients who are known to be homozygous for UGT1A1\*28 should start treatment with 50 mg/m2 ONIVYDE. If they do not encounter drug related toxicities during the first cycle of therapy (started at a reduced dose of 50 mg/m2), they may have the dose of ONIVYDE increased to a dose of 70 mg/m2 in subsequent cycles based on individual patient tolerance.
Experimental: Arm B NALIRINOX
Cycle length: 14 days~Day 1:~* Oxaliplatin 60 mg IV - Dilute in 500 mL D5W and administer over two hours (prior to leucovorin). Shorter oxaliplatin administration schedules (eg. 1mg/m2 per minute) appear to be safe.~* Leucovorin: 400 mg/m² IV - Dilute in 250 mL DSW and administer over two hours (after oxaliplatin)~* Nanoliposomal irinotecan (FBE): 50 mg/m² IV - Dilute in 500 mL D5W and administer over 90 min~* 5 FU: 2400 mg/m² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg/mL) or the total dose diluted in 100 to 150 mL NS.