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Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer (WJOG9216G)

ABSTRACT: Interventions: Arm A: FOLFIRI plus ramucirumab (Rmab) treatment - Rmab: 8 mg/kg/day1 - l-leucovorin (l-LV): 200 mg/m2/day1 - irinotecan (IRI): 180 mg/m2/day1 - bolus 5-FU: 400 mg/m2/day1 - infusional 5-FU: 2400 mg/m2/day1-3 Every 2 weeks Arm B: FOLFOXIRI plus Rmab treatment Induction therapy: 8 courses (maximum of 12 courses) - Rmab: 8 mg/kg/day1 - IRI: 165 mg/m2/day1 - l-LV: 200 mg/m2/day1 - oxaliplatin (OX): 85 mg/m2/day1 - infusional 5-FU: 3200 mg/m2/day1-3 Every 2 weeks Maintenance therapy: 5-FU/l-LV+Rmab, every 2 weeks Primary outcome(s): Objective response rate Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

DISEASE(S): First-line Treatment In Patients With Metastatic Colorectal Cancer

PROVIDER: 2614896 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Step1: Confirmation of dosage of each drug (Oxaliplatin and Irinotecan) i)Induction treatment The following drugs will be administered in 3week/cycle for 6cycles (maximum 8cycle, if investigator required). With regard to determination of oxaliplatin (OX) and Irinotecan (IRI) dosage, initial 3patients (pts) will be enrolled of level0. After finishing initial enrollment, Steering committee (SC) will evaluate safety of 3pts at the time of starting of cycle2 and will decide whether the proceeding same level (add 3 pts) or other level (level+1 or level-0.5). Final decision of Recommended Dose (RD) of OX and IRI will be required 6pts of safety evaluation in same level and will be endorsed by SC and Independent Data monitoring committee (IDMC). 1) Each drug dosage of CAPOXIRI+Bevacizumab Bevacizumab (BEV: 7.5 mg/kg, i.v., 90, 60, 30 min, Day 1) Irinotecan (IRI: 130 mg/m2, i.v., 90 min, Day 1) Oxaliplatin (OX: 200 mg/m2, i.v., 120 min, Day 1) Capecitabine (CAP: 800 mg/m2 p.o., twice daily, 14 days consecutively) 2) OX and IRI dose level Level +1: IRI: 200 mg/m2, OX:130mg/m2 Level 0: IRI: 200 mg/m2, OX:100mg/m2 Level -0.5: IRI: 180 mg/m2, OX:100mg/m2 Level -1: IRI: 150 mg/m2, OX:100mg/m2 ii)Maintenance treatment After finishing the induction treatment, investigator will select 1) 5-FU/LV+BEV (2weeks cycle) or 2) CAP+BEV treatment (3weeks/cycle). 1)5-FU/LV+BEV treatment The following drugs will be administered in 2week/cycle until meeting discontinuation criteria. - Each drug dosage of 5-FU/LV+BEV - Bevacizumab (BEV: 5.0 mg/kg, i.v., 90, 60, 30 min, Day 1) Leucovorin (LV: 200 mg/m2, i.v., 120 min, Day 1) 5-FU (3200 mg/m2, c.i.v., 48 hours, Day 1-3) 2)CAP+BEV treatment The following drugs will be administered in 2week/cycle until meeting discontinuation criteria. - Each Primary outcome(s): Progression-free survival (PFS) Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

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Randomized phase II study of FOLFIRI plus ramucirumab versus FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer (WJOG9216G)

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