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A phase I study to evaluate the effect and recommended dose of 5-FU(rapid infusion and drip infusion)/l-LV therapy for advanced and/or recurrent colon cancer (OGSG 0406)

ABSTRACT: Interventions: Agents dose rout day l-LV 200mg/m2 div(2 hours) day 1 5-FU 400mg/m2 iv(5 min) day 1 5-FU Xmg/m2 civ(46 hours) day 1 Primary outcome(s): DLT, MTD, RD Study Design: Single arm Non-randomized

DISEASE(S): Advanced/recurrent Colorectal Cancer

PROVIDER: 2616270 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

Multicenter Phase II Study of Panitumumab and Irinotecan with or without Fluoropyrimidines in patients with KRAS Wild-type Metastatic Colorectal Cancer (PACIFIC)

Project description:Interventions: Irinotecan 150 mg/m2/biweekly div l-LV 200mg/m2/biweekly div 5-FU/bolus 400mg/m2/biweekly div (bolus) 5-FU/infusional 2,400mg/m2/biweekly div Panitumumab 6mg/kg/biweekly div or S-1 80mg/m2/day p.o. day 1-7 Irinotecan 150mg/m2 day 1 Panitumumab 6mg/kg/biweekly div Irinotecan 150mg/m2/ biweekly div Panitumumab 6mg/kg/biweekly div Primary outcome(s): Progression-free survival Study Design: Parallel Randomized

| 2623074 | ecrin-mdr-crc

Phase II study of FOLFOX4 in patients with advanced/recurrent colorectal cancer previously treated with 5FU (OGSG 0503)

Project description:Interventions: FOLFOX 4 Treatment Day 1: 1. L-OHP 85mg/m2 is mixed with 250 cc of 5% glucose infusion.(A) 2. l-LV 100 mg/m2 is mixed with 250 cc of 5% glucose infusion.(B) 3. A and B are drip-infused by 2 hours using Y connection. 4. 5-FU 400mg/m2 is infused by 15 minutes, intravenously 5. 5-FU 600 mg/m2 is infused by 22 hours. Day 2: 1. l-LV 100mg/m2 is infused by 2 hours. 2. 5-FU 400 mg/m2 is infused by 15 minutes. 3. 5-FU 600 mg/m2 is infused by 22 hours Primary outcome(s): Response Rate Study Design: Single arm Non-randomized

| 2616238 | 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

Phase II study of FOLFIRI plus Bevacitumab in the treatment of Japanese patients with advanced colorectal cancer.

Project description:Interventions: (1) Bevaciumab 5mg/Kg i.v. 90min. (2) CPT-11 150mg/m2 i.v. 90min. and Isovorin 200mg/m2 i.v. 90min. (3) 5-FU 400mg/m2 i.v. bolus and 5-FU 2400mg/m2 civ. 46 hours Primary outcome(s): Progression free survival Study Design: Single arm Non-randomized

| 2616929 | ecrin-mdr-crc

Switch Maintenance Study

Project description:Interventions: CapeOX+Bev ;Capecitabine1000mg/m2 oral administration twice a day Day1-15+Oxaliplatin130mg/m2 120minute DIV+Bevacizumab5.0 mg/kg given on day 1,15 FOLFOX+Bev;Oxaliplatin85mg/m2 120minute DIV+LEVOFOLINATE200mg/m2 120minute DIV+Fluorouracil400mg/m2 rapid DIV+Fluorouracil2400mg/m2 46minute DIV+Bevacizumab DIV5.0 mg/kg Day1,15 TAS-102+Bev;TAS-102 35 mg/m2/time,oral administration twice a day Day1-5, TAS-102 oral administration twice a day Day8-12+Bevacizumab DIV5.0 mg/kg Day1,15 Primary outcome(s): Progression free survival Study Design: single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose

| 2612965 | ecrin-mdr-crc

JCOG1018: Rp3 Study in Elderly Patients with MEtastatic CRC as 1st-line Tx

Project description:Interventions: Arm A: 5-FU/LV or CAP + BEV 1. 5-FU/l-LV (msDG) + BEV (1) BEV: 5 mg/kg, iv, day 1 (2) l-LV: 200 mg/m2, iv, day 1 (3) 5-FU: 2,400 mg/m2/46 hr, civ, day 1-3 2. CAP + BEV [ 50 mL/min <= Ccr ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) CAP: 1,250 mg/m2, oral, twice a day, day 1-14 [ 30 mL/min <= Ccr<50 mL/min ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) CAP: 1,000 mg/m2, oral, twice a day, day 1-14 Arm B: 5-FU/LV or CAP + L-OHP + BEV 1. mFOLFOX7 + BEV (1) BEV: 5 mg/kg, iv, day 1 (2) l-LV: 200 mg/m2 + L-OHP:85 mg/m2, iv, day 1 (3) 5-FU: 2,400 mg/m2/46 hr, civ, day 1-3 2. CAPOX + BEV [ 50 mL/min <= Ccr ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) l-LV: 130 mg/m2, iv, day 1 (3) CAP: 1,000 mg/m2,oral, twice a day, day, day 1-14 [ 30 mL/min <= Ccr < 50 mL/min ] (1) BEV: 7.5 mg/kg, iv, day 1 (2) L-OHP: 130 mg/m2, iv, day 1 (3) CAP: 750 mg/m2, oral, twice a day, day 1-14 Primary outcome(s): Progression-free survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

| 2614012 | ecrin-mdr-crc

An exploratory study of treatment sensitivity and prognostic factors in a efficacy and safety study of mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naive unresectable advanced or recurrent colorectal cancer

Project description:Intervention name : mFOLFOX6 + panitumumab INN of the intervention : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Dosage And administration of the intervention : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks Control intervention name : mFOLFOX6 + bevacizumab INN of the control intervention : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Dosage And administration of the control intervention : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

| 2658055 | ecrin-mdr-crc

Project description:Interventions: investigational material(s) Generic name etc : mFOLFOX6 + panitumumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks control material(s) Generic name etc : mFOLFOX6 + bevacizumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

| 97976 | ecrin-mdr-crc

A phase I/II study of S-1+Irinotecan+panitumumab as first line treatment to advanced colorectal cancer

Project description:Interventions: S-1 80mg/m2 Oral administration day1-15 Irinotacan 150mg/m2 90min div day 1 Panitumumab 9mg/m2 90-30min div day 1 A single course to three weeks. Primary outcome(s): phase I: Estimated percentage of dose-limiting toxicity at first course. phase II: Response rate Study Design: Single arm Non-randomized

| 2620774 | ecrin-mdr-crc

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