First-line Therapy in Metastatic PDAC

Sponsor
Ludwig-Maximilians - University of Munich
Study ID
NCT03487016
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Arm A
  • Nab-paclitaxel — DRUG
    Arm A
  • 5-FU — DRUG
    Arm B Arm C
  • Irinotecan Liposomal Injection — DRUG
    Arm B Arm C
  • Oxaliplatin — DRUG
    Arm C

Study Details

The overarching hypothesis of this trial is that the NAPOLI regimen and alternating cycles of NAPOLI and mFOLFOX6 (seq-NAPOLI-FOLFOX) are superior to the current standard of care gemcitabine/nab-paclitaxel. Furthermore, we propose that the NAPOLI regimen and seq-NAPOLI-FOLFOX display favourable safety profiles and allow for longer first line treatment and higher rate of transition into the second line setting.

Key Dates

Start date
Feb 15, 2019
Status verified
Sep 2022
Primary completion
Jul 1, 2022
Completion
Jul 31, 2023

Study Design

Enrollment
270 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A: Gemcitabine/nab-Paclitaxel (Standard)
    Nab-paclitaxel 125 mg/m2, i.v. infusion over about 30 minutes followed by Gemcitabine 1000 mg/m2 as a 30-minute i.v. infusion on D1, D8, D15 of a 28-day cycle. Treatment is given until disease progression or the occurrence of unacceptable toxicity.
  • Experimental: B: NAPOLI regimen
    On Day 1 of a 14-day cycle: Liposomal irinotecan 80 mg/m2 i.v. over about 90 minutes followed by Folinic acid 400 mg/m2 i.v. over about 30 minutes followed by 5-FU 2400 mg/m2 i.v. over about 46 h (pump) Treatment is given until disease progression or the occurrence of unacceptable toxicity.
  • Experimental: C: seq-NAPOLI-FOLFOX
    The NAPOLI regimen and the mFOLFOX6 regimen are applied in an alternating fashion, starting with the NAPOLI regimen. NAPOLI: On Day 1 of a 14-day cycle: Liposomal irinotecan 80 mg/m2 i.v. over about 90 minutes followed by Folinic acid 400 mg/m2 i.v. over about 30 minutes followed by 5-FU 2400 mg/m2 i.v. over about 46 h (pump) mFOLFOX6: On Day 1 of a 14-day cycle: Oxaliplatin 85 mg/m2 as i.v. infusion over 2 to 6 hours according to local practice at trial site Folinic acid 400 mg/m2 as i.v. infusion; infusion duration according to local practice at trial site followed by 5-FU 2400 mg/m2 i.v. over about 46 h (pump) Treatment is given until disease progression or the occurrence of unacceptable toxicity.

Primary Outcome Measure

Progression-free survival [ Time Frame: 60 months ]

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