Second-line FOLFIRI + Panitumumab in Subjects With Wild Type RAS Metastatic Colorectal

Sponsor
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study ID
NCT03751176
Phase
PHASE2
Status
Unknown

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — DRUG
    Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy
  • Irinotecan — DRUG
    Irinotecan 180 mg/m2 will be administered as IV infusion over 90 min on day 1
  • Folinic acid — DRUG
    Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1
  • 5-FU — DRUG
    5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2

Study Details

To estimate progression-free-survival at 6 months in subjects treated in first-line with panitumumab and FOLFOX and with wild type RAS mCRC (metastatic colorectal cancer) confirmed in liquid biopsies before starting second line treatment will be screened for this trial and who have interrupted panitumumab for \<3 months (panitumumab continuation). Control arm of subjects treated with FOLFIRI alone will be included. The combinations of 5-fluorouracil (5-FU) with oxaliplatin (FOLFOX)are considered the backbone chemotherapy for mCRC. Clinical trials have shown the benefit of adding monoclonal antibodies to subjects without mutations in RAS, directed against the epidermal growth factor receptor (EGFR) (cetuximab and panitumumab) to conventional chemotherapy as first-line treatment of mCRC. This trial purposes to study the treatment beyond progression with panitumumab in subjects treated in first-line with an anti-EGFR monoclonal antibody, or rather,the re-introduction of the same targeted therapy after progression to first line. The clinical hypothesis of this study is that the second-line regimen FOLFIRI + panitumumab, is sufficiently active (defined as a 6-months PFS higher than 30% \[based on prior results with second-line FOLFIRI alone\] and of at least 50%), justifying further study in this population.

Key Dates

Start date
Nov 8, 2018
Status verified
Jun 2021
Primary completion
Nov 30, 2020
Completion
Nov 30, 2022

Study Design

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

Arms

  • Experimental: FOLFIRI + panitumumab
    Patients received panitumumab plus FOLFIRI in 14-day cycles until disease progression, unacceptable toxicity, investigator's decision or patient withdrawal of consent, at the following doses: * Panitumumab: 6 mg/kg administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy * FOLFIRI: * Irinotecan: 180 mg/m2 as IV infusion over 90 min on day 1 * Folinic acid: (leucovorin) 200-400 mg/m2 IV over 2 hours on day 1 * 5-FU: 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2
  • Active Comparator: FOLFIRI
    Patients received FOLFIRI in 14-day cycles until disease progression, unacceptable toxicity, investigator's decision or patient withdrawal of consent, at the following doses: * Irinotecan: 180 mg/m2 as IV infusion over 90 min on day 1 * Folinic acid: (leucovorin) 200-400 mg/m2 IV over 2 hours on day 1 * 5-FU: 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2

Primary Outcome Measure

Progression-free survival at 6 months [ Time Frame: 6 months after inclusion ]

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