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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

ABSTRACT: 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2658055 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (PARADIGM study)

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): efficacy Overall survival (OS) for All Participants Timeframe: Up to approximately 63 months OS will be measured as the time from the date of randomization to the date of death due to any cause. efficacy OS for Participants with Left-sided Tumors Timeframe: Up to approximately 63 months OS will be measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. Study Design: Randomized controlled trial, open, active control, parallel assignment

| 2611228 | 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: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

Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (PARADIGM study)

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): 1.Overall survival (OS) for All Participants Timeframe: Up to approximately 60 months OS will be measured as the time from the date of randomization to the date of death due to any cause. 2.OS for Participants with Left-sided Tumors Timeframe: Up to approximately 60 months OS will be measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors are defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum. Study Design: Randomized controlled trial, open, active control, parallel assignment

| 97964 | 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

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

A randomized controlled trial comparing resection of primary tumor plus chemotherapy with chemotherapy alone in incurable Stage IV colorectal cancer(JCOG1007, iPACS)

Project description:Interventions: A: Chemotherapy alone (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) B: Primary resection followed by chemotherapy (mFOLFOX6 or CapeOX plus bevacizumab; mFOLFOX6: bevacizumab 5 mg/kg IV on day 1, l-leucovorin 200 mg/m2 and oxaliplatin 85 mg/m2 as a 2-hour IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 followed by 2,400 mg/m2 IV over 46 hours, repeated every 2 weeks; CapeOX: bevacizumab 7.5 mg/kg IV on day 1, l-leucovorin 130 mg/m2 on day 1 and Capecitabine 1000 mg/m2 per day orally from day 1 to day 14, repeated every 2 weeks) Primary outcome(s): Overall survival Study Design: Parallel Randomized

| 2623557 | 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 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

Randomized phase III trial of surgery followed by mFOLFOX6 as adjuvant chemotherapy versus peri-operative mFOLFOX6 plus cetuximab for KRAS wild type resectable liver metastases of colorectal cancer

Project description:Interventions: Surgical hepatectomy followed by chemotherapy (mFOLFOX6) 12cycles. mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly) Pre-operative chemotherapy(mFOLFOX6 plus cetuximab) 6cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6 plus cetuximab) 6cycles. Cetuximab(loading dose 400mg/m2, 250 mg/m2/week), mFOLFOX6(L-OHP 85 mg/m2/biweekly, Levofolinate 200 mg/m2/biweekly, 5-FU/bolus 400 mg/m2/biweekly, 5-FU/continuous 2,400 mg/m2/biweekly) Primary outcome(s): Progression free survival Study Design: Parallel Randomized

| 2623200 | ecrin-mdr-crc

High-throughput sequencing analysis of miRNAs expression profiles in the HCT116 colorectal cancer sublines resistant to oxaliplatin (Oxa) or 5-fluorouracil (5-FU).

Project description:In the present study, we investigated miRNA expression changes caused by aquired chemoresistance to 5-FU or Oxa. 40 and 14 miRNAs were detected as differentially expressed in 5-fluouracil- and oxaliplatin-resistant colorectal HCT116 sublines, respectively. Differentially expressed miRNAs determined in the present study could be applied for further development of diagnostic and therapeutic applications for colorectal cancer carcinoma resistant to 5-FU or Oxa.

2019-12-31 | GSE119481 | GEO

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