Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT01508000
Phase
PHASE2
Status
Terminated

Conditions

  • Colorectal Cancer Metastatic
  • KRAS Wild Type Colorectal Cancer
  • Liver Metastases

Eligibility Criteria

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

Interventions

  • FOLFOX6 — DRUG
    5-FU, folinic acid, oxaliplatin
  • Bevacizumab — BIOLOGICAL
    Targeted therapy
  • Panitumumab — BIOLOGICAL
    Targeted therapy
  • Surgery — PROCEDURE

Study Details

Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy. There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended. The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome. It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study. Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery

Key Dates

First listed
Jan 11, 2012
Start date
Jun 30, 2013
Status verified
Oct 2016
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

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

Arms

  • Active Comparator: Arm A: modified FOLFOX6 and Surgery
    6 cycles before and 6 cycles after surgery consisting in: Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle
  • Experimental: Arm B: modified FOLFOX6 + Bevacizumab and Surgery
    6 cycles before and 6 cycles after surgery consisting in: Hour 0: Oxaliplatin 85 mg/m2 2-h infusion Hour 0: Folinic Acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion Hour 2 (before 5-FU bolus): Bevacizumab 5 mg/kg IV over 90 minutes infusion\*. Hour 3.5: 5-FU bolus 400 mg/m2 IV bolus over 2-4 minutes Hour 3.5: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle
  • Experimental: Arm C: modified FOLFOX6 + Panitumumab and Surgery
    Experimental: Arm B: modified FOLFOX6 + Bevacizumab and Surgery 6 cycles before and 6 cycles after surgery consisting in: Hour - 1 (pre chemotherapy): Panitumumab 6 mg/kg IV over 60 minutes (≤ 1000 mg) or 90 minutes (\> 1000 mg) +/- 15 min. infusion\*. Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle

Primary Outcome Measure

Progression free survival [ Time Frame: 1 year ]

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