Escalated Dose of Irinotecan in mCRC

NACompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

August 13, 2014

Primary Completion Date

November 30, 2017

Study Completion Date

November 30, 2017

Conditions
Metastatic Colorectal Cancer
Interventions
GENETIC

UGT1A1 genotyping (6,6)

"The investigators will use the regimen as following:~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.~After 2 cycles of each different dose of irinotecan, we will observe the adverse effects (AEs) of hematological / non-hematological. If the grade is under the grade 2, we will escalate the dose of 30 mg/m2 gradually. The estimated maximal dose of irinotecan is 260 mg/m2."

GENETIC

UGTIA1 genotyping (6,7)

"The investigators will use the regimen as following:~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.~After 2 cycles of each different dose of irinotecan, we will observe the adverse effects (AEs) of hematological / non-hematological. If the grade is under the grade 2, we will escalate the dose of 30 mg/m2 gradually. The estimated maximal dose of irinotecan is 240 mg/m2."

GENETIC

UGTIA1 genotyping (7,7)

"The investigators will use the regimen as following:~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (120 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.~After 2 cycles of each different dose of irinotecan, we will observe the adverse effects (AEs) of hematological / non-hematological. If the grade is under the grade 2, we will escalate the dose of 30 mg/m2 gradually. The estimated maximal dose of irinotecan is 180 mg/m2."

GENETIC

UGT1A1 non-genotyping

"The investigators will use the regimen as following:~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks."

DRUG

bevacizumab (Avastin)

bevacizumab as target therapy

DRUG

irinotecan

irinotecan as escalating dose according to UGT1A1 genotyping

DRUG

Leucovorin

combined with 5-FU

DRUG

5-FU

combined with irinotecan

Trial Locations (1)

807

Chung-Ho Memorial Hospital, Kaohsiung Medical University:, Kaohsiung City

All Listed Sponsors
lead

Jaw-Yuan Wang, MD, PhD

OTHER

NCT02256800 - Escalated Dose of Irinotecan in mCRC | Biotech Hunter | Biotech Hunter