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Phase II study of FOLFIRI+Ramucirumab with early recurrent colorectal cancer refractory to adjuvant chemotherapy with oxaliplatin / fluoropyrimidine(RAINCLOUD)

ABSTRACT: Interventions: FOLFIRI+Ramucirumab (5-FU(bolus): 400mg/m2 on day1, 5-FU(ci): 2,400mg/m2 on day1-3 (46hr), l-LV: 200mg/m2 on day1, CPT-11: 180*mg/m2 on day1, Ramucirumab: 8mg/kg on day1) *Allow dose level -1 (150mg/m2) Primary outcome(s): Progression-Free Survival (PFS) Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2643874 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II study of FOLFIRI+Ramucirumab with recurrent colorectal cancer refractory to adjuvant chemotherapy (RAINCLOUD).RAINCLOUD-TR.

Project description:Interventions: FOLFIRI+Ramucirumab (5-FU(bolus): 400mg/m2 on day1, 5-FU(ci): 2,400mg/m2 on day1-3 (46hr), l-LV: 200mg/m2 on day1, CPT-11: 180mg/m2 on day1, Ramucirumab: 8mg/kg on day1) *Allow dose level -1 (150mg/m2) RAINCLOUD-TR Collecting blood 12mL at the time of before RAINCLOUD protocol treatment, and PD. Primary outcome(s): Progression free survival Study Design: single arm study, open(masking not used), no treatment control/standard of care control, parallel assignment, treatment purpose

| 2615323 | ecrin-mdr-crc

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

Project description: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

| 2614896 | ecrin-mdr-crc

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

Project description:Interventions: Arm A: FOLFIRI+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 eeks Arm B: FOLFOXIRI+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 oxaaliplatin (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 week Primary outcome(s): Objective response rate Study Design: Parallel Randomized

| 2641746 | ecrin-mdr-crc

Phase II study of second-line chemotherapy using modified FOLFOX6 in patients with advanced/ recurrent colorectal cancer (OGSG 0505)

Project description:Interventions: DAY 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ....... | 5-FU 400mg/m2 iv Rapid Primary outcome(s): Response Rate(RECIST), Duration of response Study Design: Single arm Non-randomized

| 2616344 | ecrin-mdr-crc

Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial

Project description:The RANGE study (NCT02426125) evaluated ramucirumab (an anti-VEGFR2 monoclonal antibody) in patients with platinum-refractory advanced urothelial carcinoma (UC). Here, we use programmed cell death-ligand 1 (PD-L1) immunohistochemistry (IHC) and transcriptome analysis to evaluate the association of immune and angiogenesis pathways, and molecular subtypes, with overall survival (OS) in UC. Higher PD-L1 IHC and immune pathway scores, but not angiogenesis scores, are associated with greater ramucirumab OS benefit. Additionally, Basal subtypes, which have higher PD-L1 IHC and immune/angiogenesis pathway scores, show greater ramucirumab OS benefit compared to Luminal subtypes, which have relatively lower scores. Multivariable analysis suggest patients from East Asia as having lower immune/angiogenesis signature scores, which correlates with decreased ramucirumab OS benefit. Our data highlight the utility of multiple biomarkers including PD-L1, molecular subtype, and immune phenotype in identifying patients with UC who might derive the greatest benefit from treatment with ramucirumab. Please note that the RANGE clinical trial data generated in this study have been deposited at www.vivli.org. RANGE clinical trial data are available under restricted access to protect patient privacy, and access can be obtained by submitting a request. For details on submitting a request, see the instructions provided at www.vivli.org. For specific study details, see here: https://search.vivli.org/?search=NCT02426125.

2022-03-14 | GSE198269 | GEO

Phase II Study of Panitumumab with Fluorouracil in Patients With KRAS Wild-type Metastatic Colorectal Cancer(PF Study)

Project description:Interventions: l-LV 200mg/m2 day 1 5-FU/bolus 400mg/m2 day1 5-FU/infusional 2,400mg/m2 day1-2 Panitumumab 6mg/kg day 1 Biweekly or Capecitabine 2,000mg/m2/day day1-7 Panitumumab 6mg/kg day1 Biweekly or S-1 80mg/m2/day day1-7 Panitumumab 6mg/kg day1 Biweekly or UFT 300mg/m2/day day1-7 LV 75 mg/m2/day day1-7 Panitumumab 6mg/kg day1 Biweekly Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2622610 | ecrin-mdr-crc

Feasibility study of Pre-operative FOLFIRI3 plus cetuximab for KRAS wild type resectable advanced colorectal cancer (mCRC).

Project description:Interventions: Pre-operative chemotherapy(FOLFIRI3 plusCetuximab)4cycles =>To evaluate effect =>Surgical resection or Continued chemotherapy =>Surgical resection. *FOLFIRI3 plus Cetuximab Cetuximab500 mg/m2/day1/q2w CPT-11 100 mg/m2/day1,3/q2w I-LV 200 mg/m2/day1/q2w 5-FU/infusional 2400 mg/m2/46hr/q2w Primary outcome(s): Treatment completion rate Study Design: Single arm Non-randomized

| 2625026 | ecrin-mdr-crc

Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer

Project description:Interventions: Group A:mFOLFOX6 Day 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ------------- | 5-FU 400mg/m2 iv Rapid Group B:TS-1/CPT-11 CPT-11 80 mg/m2CPT-11 80 mg/m2 1.5 hours 1.5 hours TS-1 40-60 mg/m2 | | | | Day 1 day 15 day 21 day 35 One course takes 35 days (5 weeks). Primary outcome(s): Response Rate(RECIST) Study Design: Parallel Randomized

| 2616289 | ecrin-mdr-crc

study of medical treatment reactivity by the chemokine receptor (CXCR4)as 1st line treatment in patients with metastatic colorectal cancer

Project description:Interventions: CXCR4-CEC>=20 mFOLFOX6,Bevacizumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Bevacizumab:5mg/m2 CXCR4-CEC>=20 mFOLFOX6,Panitumumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Panitumumab :6mg/m2 CXCR4-CEC<20 mFOLFOX6,Bevacizumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Bevacizumab:5mg/m2 CXCR4-CEC<20 mFOLFOX6,Panitumumab L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 Panitumumab :6mg/m2 Primary outcome(s): Progression-free survival Study Design: Parallel Randomized

| 2623948 | ecrin-mdr-crc

Phase II clinical trial of Cetuximab with Fluorouracil therapy for patients refractory or intolerable to Oxaliplatin and Irinotecan with KRAS wild-type unresectable/recurrent colorectal cancer

Project description:Interventions: (Cetuximab with Fluorouracil therapy) Cetuximab=400mg/m2 (day1)Cetuximab=250mg/m2/weekly(day 8-) with 1) l-LV=200mg/m2/bi-week 5-FU/bolus=400mg/m2/bi-week 5-FU/infusional=2,400mg/m2/bi-week (day1-3) 2) LV=75mg/day (*Administration for 4weeks and Drug withdrawal for one week)UFT=300-600mg/day* 3) Capecitabine=2,000mg/m2/day(*Administration for 2weeks and Drug withdrawal for one week) 4) S-1=80-120mg/day (*Administration for 2weeks and Drug withdrawal for one week) Primary outcome(s): Progression-free survival; PFS Study Design: Single arm Non-randomized

| 2623785 | ecrin-mdr-crc

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