Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

Sponsor
Fujian Cancer Hospital
Study ID
NCT03222089
Phase
PHASE2
Status
Withdrawn

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Irinotecan 165 mg/m² 1-hour IV day 1
  • Oxaliplatin — DRUG
    oxaliplatin 85 mg/m² 2-hours IV day 1
  • Levoleucovorin — DRUG
    Levoleucovorin 200 mg/m² 2-hours IV day 1
  • 5-FU — DRUG
    5-FU 2800 mg/m² 46-hours flat continuous infusion IV
  • GM-CSF — DRUG
    GM-CSF 150ug s.c. d3-7 , Repeated every 4 weeks.
  • IL-2 — DRUG
    Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks.

Study Details

A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.

Key Dates

Start date
Jul 20, 2017
Status verified
Mar 2018
Primary completion
Jul 20, 2019
Completion
Jul 20, 2020

Study Design

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

Arms

  • Experimental: FOLFOXIGIL
    The FOLFOXIGIL chemoimmunotherapy regimen is composed by FOLFOXIRI chemotherapy and the immunotherapy of GM-CSF and IL-2. FOLFOXIRI: Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + Levoleucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1, repeated every 2 weeks. GM-CSF 150ug s.c. d3-7; Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity.
  • Active Comparator: FOLFOXIRI
    Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + Levoleucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1, Repeated every 2 weeks. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity.

Primary Outcome Measure

Progression-free survival (PFS) rate at 10 months [ Time Frame: PFS rate at 10 months from study entry ]

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