Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01878422
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2013-06-07
Brief Title:
Sequential Treatment Strategy for Metastatic Colorectal Cancer
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
SEQUENTIAL TREATMENT STRATEGY FOR METASTATIC COLORECTAL CANCER A PHASE III PROSPECTIVE RANDOMIZED MULTICENTER STUDY OF CHEMOTHERAPY CT WITH OR WITHOUT BEVACIZUMAB AS FIRST-LINE THERAPY FOLLOWED BY TWO PHASE III RANDOMIZED STUDIES OF CT ALONE OR CT PLUS BEVACIZUMAB WITH OR WITHOUT CETUXIMAB AS SECOND-LINE THERAPY
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITACa
Brief Summary:
Study Design This is a pragmatic study on the management strategy for patients with metastatic colorectal cancer CRC who are candidates for CT independently of any previous adjuvant therapy received The aim of this study is to define the role of new target molecules in combination with CT in first- and second line treatment
First line study Eligible patients were randomized to either treatment
Arm A FOLFIRI or FOLFOX Bevacizumab cycle to be repeated every 2 weeks
BEVACIZUMAB Day 11st cycle 5 mgkg IV infusion of 90 min Day 1 2nd cycle if well tolerated 5 mgkg IV infusion of 60 min Day 1 3rd cycle and subsequent cycles if well tolerated 5 mgkg IV infusion of 30 min after 5-Fluorouracile FU bolus
FOLFIRI Day 1 Irinotecan 180 mgm2 IV infusion 30-90 min
Day 12
L-Folinic acid 100 mgm2 IV infusion of 2 hours 5-Fluorouracil 400 mgm2 as a bolus 5-Fluorouracil 600 mgm2 continuous IV infusion of 22 hours - FOLFOX Day 1 Oxaliplatin 85 mgm2 IV infusion of 2hours
Day 12
L-Folinic acid 100 mgm2 IV infusion of 2 hours 5-Fluorouracil 400 mgm2 as a bolus 5-Fluorouracil 600 mgm2 continuous IV infusion of 22 hours Arm B FOLFIRI or FOLFOX cycle to be repeated every 2 weeks If FOLFIRI FOLFIRI as specified in arm A without Bevacizumab If FOLFOX FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms CT was repeated until progressive disease PD or unacceptable toxicity occurs If unacceptable CT-related toxicity occurs in ARM A in the absence of PD patients stopped CT and continued with only bevacizumab 5 mgkg as a 30-min infusion every 2 weeks until progression or intolerable toxicity occurred
Second line - it is divided in two different studies 2A and 2B
Study 2A Patients from arm A and Kras Wild Type were randomized to
Arm C FOLFIRI or FOLFOX the CT schedule not received in 1st line trial as defined in arm B
Arm D FOLFIRI or FOLFOX the CT schedule not received in 1st line trial as described in arm B plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mgm2 infusion of 120 min 2 hrs before CT infusion 1st cycle Day 8 and subsequent cycles 250 mgm2 infusion of 60 min 1 hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm C
Study 2B Patients from arm B and Kras Wild Type were randomized to
Arm E FOLFIRI or FOLFOX the CT schedule not received in the 1st line trial as defined in arm B plus BEVACIZUMAB
Arm F FOLFIRI or FOLFOX the CT schedule not received in the first-line trial as defined in arm B plus BEVACIZUMAB and CETUXIMAB cycle to be repeated every 2 weeks whilst cetuximab will be administered weekly
BEVACIZUMAB 2nd day of 1st cycle 5 mgkg IV infusion of 90 min 2nd day of 2 nd cycle if well tolerated 5 mgkg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent cycles if well tolerated 5 mgkg IV infusion of 30 min after the end of 5-FU bolus on the 2nd day
CETUXIMAB 1st cycle Day 1 400 mgm2 infusion of 120 min 2 hr before CT infusion 1st cycle Day 8 and subsequent cycles 250 mgm2 infusion of 60 min 1 hr before CT infusion If cetuximab will be stopped for any of the reasons specified in this protocol bevacizumab will be administered as defined in arm A of the 1st line study Patients from arm B and Kras Mutant were treated according to arm E Objectives of study The primary objective of the 1st line study is to determine whether the addition of bevacizumab to a poly-chemotherapy polyCT regimen FOLFIRI or FOLFOX improves efficacy in terms of progression-free survival PFS The secondary objectives of the 1st line study are to determine the Overall Response Rate ORR and the safety profile of the treatments administered
The primary objective of the 2nd line studies is to determine separately for each study whether the addition of cetuximab to a polyCT schemes FOLFOX or FOLFIRI or to polyCT schemes plus bevacizumab improves efficacy in terms of PFSThe secondary objectives of the 2nd line studies are to determine the ORR the overall survival OS and the safety profile of the treatments administered
First line study Eligible patients were randomized to either treatment
Arm A FOLFIRI or FOLFOX Bevacizumab cycle to be repeated every 2 weeks
BEVACIZUMAB Day 11st cycle 5 mgkg IV infusion of 90 min Day 1 2nd cycle if well tolerated 5 mgkg IV infusion of 60 min Day 1 3rd cycle and subsequent cycles if well tolerated 5 mgkg IV infusion of 30 min after 5-Fluorouracile FU bolus
FOLFIRI Day 1 Irinotecan 180 mgm2 IV infusion 30-90 min
Day 12
L-Folinic acid 100 mgm2 IV infusion of 2 hours 5-Fluorouracil 400 mgm2 as a bolus 5-Fluorouracil 600 mgm2 continuous IV infusion of 22 hours - FOLFOX Day 1 Oxaliplatin 85 mgm2 IV infusion of 2hours
Day 12
L-Folinic acid 100 mgm2 IV infusion of 2 hours 5-Fluorouracil 400 mgm2 as a bolus 5-Fluorouracil 600 mgm2 continuous IV infusion of 22 hours Arm B FOLFIRI or FOLFOX cycle to be repeated every 2 weeks If FOLFIRI FOLFIRI as specified in arm A without Bevacizumab If FOLFOX FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms CT was repeated until progressive disease PD or unacceptable toxicity occurs If unacceptable CT-related toxicity occurs in ARM A in the absence of PD patients stopped CT and continued with only bevacizumab 5 mgkg as a 30-min infusion every 2 weeks until progression or intolerable toxicity occurred
Second line - it is divided in two different studies 2A and 2B
Study 2A Patients from arm A and Kras Wild Type were randomized to
Arm C FOLFIRI or FOLFOX the CT schedule not received in 1st line trial as defined in arm B
Arm D FOLFIRI or FOLFOX the CT schedule not received in 1st line trial as described in arm B plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mgm2 infusion of 120 min 2 hrs before CT infusion 1st cycle Day 8 and subsequent cycles 250 mgm2 infusion of 60 min 1 hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm C
Study 2B Patients from arm B and Kras Wild Type were randomized to
Arm E FOLFIRI or FOLFOX the CT schedule not received in the 1st line trial as defined in arm B plus BEVACIZUMAB
Arm F FOLFIRI or FOLFOX the CT schedule not received in the first-line trial as defined in arm B plus BEVACIZUMAB and CETUXIMAB cycle to be repeated every 2 weeks whilst cetuximab will be administered weekly
BEVACIZUMAB 2nd day of 1st cycle 5 mgkg IV infusion of 90 min 2nd day of 2 nd cycle if well tolerated 5 mgkg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent cycles if well tolerated 5 mgkg IV infusion of 30 min after the end of 5-FU bolus on the 2nd day
CETUXIMAB 1st cycle Day 1 400 mgm2 infusion of 120 min 2 hr before CT infusion 1st cycle Day 8 and subsequent cycles 250 mgm2 infusion of 60 min 1 hr before CT infusion If cetuximab will be stopped for any of the reasons specified in this protocol bevacizumab will be administered as defined in arm A of the 1st line study Patients from arm B and Kras Mutant were treated according to arm E Objectives of study The primary objective of the 1st line study is to determine whether the addition of bevacizumab to a poly-chemotherapy polyCT regimen FOLFIRI or FOLFOX improves efficacy in terms of progression-free survival PFS The secondary objectives of the 1st line study are to determine the Overall Response Rate ORR and the safety profile of the treatments administered
The primary objective of the 2nd line studies is to determine separately for each study whether the addition of cetuximab to a polyCT schemes FOLFOX or FOLFIRI or to polyCT schemes plus bevacizumab improves efficacy in terms of PFSThe secondary objectives of the 2nd line studies are to determine the ORR the overall survival OS and the safety profile of the treatments administered
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-004539-44 | EUDRACT_NUMBER | None | None |