A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

PHASE3CompletedINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

December 2, 2013

Primary Completion Date

November 20, 2017

Study Completion Date

June 30, 2018

Conditions
Colorectal NeoplasmsNeoplasm MetastasisIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System Neoplasms
Interventions
BIOLOGICAL

Bevacizumab

5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.

DRUG

CPT-11 (Irinotecan)

150-180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle.

DRUG

5-FU Bolus

400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.

DRUG

5-FU Infusion

2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.

DRUG

l-LV (dl-LV)

200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.

BIOLOGICAL

bevacizumab

7.5mg/kg IV intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on Day 1 of a 3-week cycle.

DRUG

CPT-11 (Irinotecan)

150-200 mg/m2 intravenously administered over 90 minutes on day 1 of a 3-week cycle.

DRUG

Capecitabine

1600mg/m2/day oral on day 1 (evening) to day 15 (morning)of a 3-week cycle.

Trial Locations (1)

606-8392

NPO Epidemiological and Clinical Research Information Network (ECRIN), Kyoto

All Listed Sponsors
lead

Epidemiological and Clinical Research Information Network

OTHER

NCT01996306 - A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC | Biotech Hunter | Biotech Hunter