A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC (QUATTRO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02246049|
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : June 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Biological: Bevacizumab Drug: 5-fluorouracil Drug: Irinotecan hydrochloride Drug: Leucovorin calcium Drug: Oxaliplatin||Phase 2|
This is a single-arm, multicentre phase II study evaluating the efficacy and safety of Bevacizumab (BV) in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium regimen ( FOLFOXIRI +BV ; Falcone et al. ASCO2013) as first-line treatment for Japanese metastatic colorectal cancer patients.
This study is composed two steps because of collecting safety issue in Japanese patient.
As First step (Step 1), It assess on the initial safety information in ten Japanese patients of the end of 2nd cycle. it is evaluated by DMC.
In parallel with the confirmation of the initial safety issue, register up to 65 cases in total and Step 1 patient, to evaluate the efficacy and safety (Step2).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Clinical Phase II Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With Metastatic Colorectal Cancer|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: FOLFOXIRI plus bevacizumab
Induction therapy is followed by the maintenance therapy.
[Induction treatment:FOLFOXIRI plus bevacizumab] Administered for a maximum of 12 cycles. BV: 5mg/kg (d.i.v.) L-OHP: 85 mg/sq.m (d.i.v.) CPT-11:165mg/sq.m (d.i.v.) l-LV:200mg/sq.m (d.i.v.) 5-FU:3,200mg/sq.m (c.i.v.) Administered every 2 weeks.
[Maintenance treatment:5-FU / I-LV plus bevacizumab] BV:5mg/kg (d.i.v.) l-LV:200mg/sq.m (d.i.v.) 5-FU:3,200mg/sq.m (c.i.v.) Administered every 2 weeks.
Other Name: BV
Other Name: 5-FU
Drug: Irinotecan hydrochloride
Other Name: CPT-11
Drug: Leucovorin calcium
Other Name: I-LV
Other Name: L-OHP
- Progression-free survival (PFS) at 10 months [ Time Frame: PFS rate at 10 months from study entry ]
PFS by investigator-reported measurements according to CT image. PFS was calculated from the day of treatment start to the first observation of progression disease (PD) or death from any cause.
PD was defined as Overall Response by RECIST criteria v1.1 according to CT image.
- Response rate (RR) by central review. [ Time Frame: Up to 18 months ]Response evaluation was performed according to RECIST criteria v1.1.
- Response rate (RR) by investigator-reported measurements. [ Time Frame: Up to 30 months ]Response evaluation was performed according to RECIST criteria v1.1.
- PFS by central review according to CT image. [ Time Frame: Up to 18 months ]PFS was calculated from the day of treatment start to the first observation of progression disease (PD) or death from any cause.
- Overall survival (OS) [ Time Frame: Up to 30 months ]OS was calculated from the day of registration in this study to death from any cause.
- Efficacy by RAS status ; RR,PFS,OS [ Time Frame: Up to 30 months ]RR,PFS,OS according to tumor RAS status.
- Incidence of adverse events [ Time Frame: Up to 30 months ]Adverse events were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All adverse events was collected in duration from starting treatment to whichever shorter "after 30 days from withdrawal treatment" or "later treatment was started".
- Time to treatment-failure [ Time Frame: Up to 30 months ]
- Completion rate in Induction treatment [ Time Frame: Up to 30 months ]
- Relative Dose Intensity [ Time Frame: Up to 30 months ]
- Treatment duration [ Time Frame: Up to 30 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246049
|Shinjuku, Tokyo, Japan, 162-0814|
|Principal Investigator:||Takeshi Kato, M.D., Ph.D||Department of Surgery, National Hospital Organization Osaka National Hospital.|
|Principal Investigator:||Akiyoshi Kanazawa, M.D., Ph.D||Department of Surgery, Shimane Prefectural Central Hospital.|